Clinical Trials Actively Recruiting

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below

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Results 1 - 10 of 240

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and NAB-Paclitaxel versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers
Objective:
Primary Objective(s):

To compare overall survival (OS) in patients with untreated, advanced biliary cancers treated with gemcitabine and cisplatin (GC) versus those treated with gemcitabine, cisplatin, and nab-Paclitaxel (GCN)

Secondary Objective(s):

To compare progression-free survival (PFS) in patients treated with GC versus GCN

To compare overall response rate (ORR), complete and partial, confirmed and unconfirmed, in the subset of patients with measurable disease treated with GC versus GCN

To compare disease control rate [confirmed and unconfirmed; complete response + partial response + stable disease] (DCR) in patients treated with GC versus GCN

To evaluate the frequency and severity of toxicity associated with GC and GCN in the patient population

To explore the correlation between change in CA 19-9 levels from baseline to posttreatment (after 3 cycles) and overall response rate, in each treatment arm separately and in the total cohort
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Tesfaye, Anteneh
Karmanos Trial ID:
S1815
Age Group:
Adult
Phase:
Phase III
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A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma
Objective:
Primary Objective:

To compare the progression-free survival (PFS) in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD (nivolumab, doxorubicin, vinblastine, dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).

Secondary Objectives:

To compare overall survival (OS) in patients randomized to N-AVD versus BV-AVD.

To compare event-free survival (EFS) in patients randomized to N-AVD versus BV-AVD.

To compare the metabolic complete response (CR) rate at the end of treatment in patients randomized to N-AVD versus BV-AVD.

To compare the physician-reported treatment-related adverse event rates between arms stratified by age groups.

To compare patient-reported symptoms using selected PRO-CTCAE items between arms stratified by age groups.

To compare the safety and tolerability of N-AVD versus that of BV-AVD.
Cancer Categories:
Hematologic (Blood Cancers)
Principal Investigator:
Seymour, Erlene
Karmanos Trial ID:
S1826
Age Group:
Both
Phase:
Phase III
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A Randomized Trial of the Altering Intake, Managing Symptoms Intervention for Bowel Dysfunction in Rectal Cancer Survivors Compared to a Healthy Living Education Control: A Feasibility and Preliminary Efficacy Study (AIMS-RC)
Objective:
Primary Objective:

To compare total bowel function score, as measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI), at 18 weeks post-randomization between the intervention and attention control arms.
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Tesfaye, Anteneh
Karmanos Trial ID:
S1820
Age Group:
Adult
Phase:
Phase II
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Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma
Objective:

Primary Objectives

To evaluate whether progression-free survival (PFS) meets an efficacy threshold in patients with previously treated advanced small bowel adenocarcinoma who receive treatment with ramucirumab and paclitaxel or FOLFIRI.

If the stated threshold is met in both arms, to choose the better regimen with respect to PFS.

Secondary Objectives

To assess overall response rate (ORR) [complete and partial, confirmed and unconfirmed] in the subset of patients with measurable disease treated with ramucirumab and paclitaxel or FOLFIRI in this patient population.

To assess overall survival (OS) in patients treated with ramucirumab and paclitaxel or FOLFIRI in this patient population.

To evaluate safety and toxicity associated with combination ramucirumab and paclitaxel treatment or FOLFIRI therapy in this patient population.
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Shields, Anthony
Karmanos Trial ID:
S1922
Age Group:
Adult
Phase:
Phase II
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A Randomized Phase II Study of Trastuzmab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (MCRC) with HER-2 Amplification
Objective:
Primary Objective:

To evaluate the efficacy of trastuzumab and pertuzumab (TP) in HER-2 amplified metastatic colorectal cancer (mCRC) by comparing progression-free survival (PFS) on TP compared to control arm of cetuximab and irinotecan (CETIRI).

Secondary Objectives:

To evaluate the overall response rate (ORR), including confirmed complete and partial response per RECIST 1.1, in the TP and CETIRI treatment arms.

To evaluate the overall survival (OS) in the TP and CETIRI treatment arms.

To evaluate the safety and toxicity of TP compared to CETIRI.
Cancer Categories:
Gastrointestinal (GI)
Principal Investigator:
Tesfaye, Anteneh
Karmanos Trial ID:
S1613
Age Group:
Adult
Phase:
Phase II
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A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
Objective:
Primary Objectives:

Phase II:

Determine the feasibility of conducting a cooperative group prospective clinical trial in patients with resected malignant salivary gland tumors;

Acquire preliminary efficacy data comparing postoperative radiotherapy alone to concurrent chemotherapy and radiation using weekly cisplatin.

Phase III:

Compare overall survival rates among patients receiving cisplatin and radiation to those receiving radiation alone.

Secondary Objectives:

Phase II/III

Compare the acute toxicities of these 2 adjuvant treatments;

Compare late treatment-related adverse events in patients receiving postoperative radiation to those receiving concurrent chemoradiation;

Compare progression-free survival rates among patients receiving cisplatin and radiation to those receiving radiation alone in both the cohort of patients with pathologically high-risk disease (high-grade adenocarcinoma, high-grade mucoepidermoid carcinoma, salivary duct carcinoma), and the patient cohort with pathologically intermediate-risk disease (all other eligible diagnoses).

Investigate quality of life and patient-reported outcomes in patients enrolled in the study;

Identify the histopathology and tumor marker expression from patients enrolled on this trial and assemble a tissue bank for future correlative studies;
Cancer Categories:
Head and Neck
Principal Investigator:
Sukari, Ammar
Karmanos Trial ID:
RTOG-1008
Age Group:
Adult
Phase:
Phase II/III
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A Randomized Phase III Clinical Trial Evaluating Post Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axilla
Objective:
Primary Objective(s):

To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.

Secondary Objective(s):

Overall survival (OS) Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly prolong OS in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.

Loco-regional recurrence-free interval (LRRFI) Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rates of events for LRRFI in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.

Distant recurrence-free interval (DRFI) Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for DRFI in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.

Disease-free survival-ductal carcinoma in situ (DFS-DCIS) Aim: To compare the rates of DFS-DCIS by treatment arm.

Second primary invasive cancer Aim: To compare the rates of second primary invasive cancer by treatment arm.

Quality of life Aim: 2) To compare the effect of adding XRT on the cosmetic outcomes in mastectomy patients who have had reconstruction. 2) To compare the effect of adding XRT on quality of life including arm problems, lymphedema, pain, and fatigue.

Toxicity Aim: To evaluate the toxicity associated with each of the radiation therapy regimens.

Treatment adequacy Aim: To determine whether CT-based conformal methods (IMRT and 3DCRT) for chestwall + regional nodal XRT post mastectomy and regional nodal XRT with breast XRT following breast conserving surgery are feasible in a multi-institutional setting and whether dose-volume analyses can be established to assess treatment adequacy and to develop normal tissue complication probabilities (NTCP) for the likelihood of toxicity.

Effect of XRT Aim: To compare the effect of XRT in patients receiving mastectomy and in patients receiving lumpectomy.

Molecular predictors of recurrence Aim: 1) To examine the role of proliferation measures as a prognosticator for patients with residual disease after neoadjuvant chemotherapy. 2) To develop predictors of the degree of reduction in LRR.
Cancer Categories:
Breast
Principal Investigator:
Vaishampayan, Nitin
Karmanos Trial ID:
RTOG1304
Age Group:
Adult
Phase:
Phase III
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Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab
Objective:
Primary Objective(s):

Phase II: To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab.

Phase III: To compare overall survival (OS) for patients with LS-SCLC treated with chemoradiation +/- atezolizumab.

Secondary Objective(s):

To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab. (phase III)

To determine overall response rate (ORR), rates of local control, and distant metastases free survival with chemoradiation +/- atezolizumab

To characterize immune mediated and non-immune mediated toxicity from chemoradiotherapy plus atezolizumab

To compare quality of life, as measured by the FACT-TOI, for patients undergoing chemoradiation +/- atezolizumab

To evaluate the quality-adjusted survival, using scores from the EQ-5D-5L, of chemoradiation +/- atezolizumab for patients with LS-SCLC

To characterize fatigue, as measured by the PROMIS, following chemoradiation +/- atezolizumab

To determine the association of blood based tumor mutational burden (bTMB) and tissue-based tumor mutational burden (tTMB) with clinical outcome
Cancer Categories:
Lung
Principal Investigator:
Devisetty, Kiran
Karmanos Trial ID:
NRG-LU005
Age Group:
Adult
Phase:
Phase II/III
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Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial
Objective:

Primary Objectives
Phase II:

To evaluate the impact of adding LCT (local consolidative therapy) to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy

Phase III:

To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy

Secondary Objectives

To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure;

To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on the time to development of new lesions;

To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity;

To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on duration of maintenance systemic therapy usage.

To evaluate the effect of adding LCT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL)

To collect biospecimens and evaluate the correlation between clinical outcomes and circulating tumor DNA (ctDNA)
Cancer Categories:
Lung
Principal Investigator:
Miller, Steven
Karmanos Trial ID:
NRG-LU002
Age Group:
Adult
Phase:
Phase II/III
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Phase I Trial of Accelerated or Conventionally Fractionated Radiotherapy Combined With MEDI4736 (Durvalumab) in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (ARCHON-1)
Objective:

Primary Objective

To evaluate if the addition of MEDI4736 (durvalumab) to two schedules of radiation therapies (60 Gy in 30 fractions or 60 Gy in 15 fractions) is safe.

Secondary Objectives

To examine if the addition of MEDI4736 (durvalumab) to radiation therapy is feasible.

To assess toxicities associated with the addition of MEDI4736 (durvalumab) to radiation therapy.

To obtain preliminary estimates of progression-free survival (PFS), using RECIST guidelines, in patients who received MEDI4736 (durvalumab) added to radiation. Although the clinical benefit of MEDI4736 (durvalumab) in combination with radiotherapy has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response.
Cancer Categories:
Lung
Principal Investigator:
Bhatt, Amit
Karmanos Trial ID:
NRG-LU004
Age Group:
Adult
Phase:
Phase I
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