← Back to Search

Alkylating agents

Chemotherapy + Allopurinol + Mycophenolate for Small Cell Lung Cancer

Phase 1 & 2
Recruiting
Led By Siddhartha Devarakonda, MBBS, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤ 2
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 6 months after completion of treatment (estimated to be 10 months)
Awards & highlights

Study Summary

This trial is testing whether adding mycophenolate mofetil and allopurinol to chemotherapy drugs used for relapsed small cell lung cancer will improve outcomes compared to using other single agent chemotherapy drugs.

Who is the study for?
This trial is for adults with small cell lung cancer that's come back after platinum-based chemo and anti-PD-L1 therapy. They must have measurable disease, be able to perform daily activities (ECOG ≤ 2), and have normal organ function. Participants need to use contraception and can't join if they've had certain infections or treatments recently, other cancers, intolerances to specific drugs, active autoimmune diseases, HIV/AIDS, hepatitis B/C, brain metastases requiring treatment or are pregnant/breastfeeding.Check my eligibility
What is being tested?
The CLAMP Trial tests whether adding mycophenolate mofetil (MMF) and allopurinol to the chemotherapy drug irinotecan improves outcomes for relapsed small cell lung cancer patients. It aims to see if this combination is safe and increases the time without disease progression compared to past single-agent chemotherapies.See study design
What are the potential side effects?
Possible side effects include immune system suppression leading to increased infection risk; gastrointestinal issues like nausea or diarrhea; liver problems; potential first trimester pregnancy loss or birth defects if taken during pregnancy; allergic reactions similar in nature to those caused by MMF or allopurinol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Select...
My small cell lung cancer worsened after treatment with platinum-based chemo and anti-PD-L1.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 6 months after completion of treatment (estimated to be 10 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 6 months after completion of treatment (estimated to be 10 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of DLTs in Phase I patients
Number of discontinuations due to treatment related adverse events (Phase I only)
Number of study treatment related adverse events as measured by NCI-CTCAE v 5.0 (Phase I only)
+2 more
Secondary outcome measures
Overall survival (OS) (Phase II and phase I patients who receive the MTD)
Progression-free survival (PFS) (Phase II and phase I patients who receive the MTD)

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478
23%
Blood/Bone marrow
11%
Cardiovascular
9%
Pulmonary
7%
Gastrointestinal
7%
Hepatic
5%
Graft versus host disease with infection and organ failure
2%
Dermatology/Skin
2%
respiratory failure
2%
Hemorrhage
2%
subdural hematoma
2%
thrombosis
2%
Renal/Genitourinary
2%
Metabolic/Laboratory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (TBI, Transplant, GVHD Prophylaxis)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Phase II: MMF + Irinotecan + AllopurinolExperimental Treatment3 Interventions
-Mycophenolate mofetil (MMF) will be administered at a dose of 1 g TID (3 g/day) on a daily basis (Days 1 through 21). Allopurinol will be administered at dose of 300 mg/day on a daily basis (Days 1 through 21). Irinotecan will be given at the assigned dose level on Days 1 and 8. Cycles are 21 days.
Group II: Phase I Dose Level 1a: MMF + Irinotecan + AllopurinolExperimental Treatment3 Interventions
-Mycophenolate mofetil (MMF) will be administered at a dose of 1 g TID (3 g/day) on a daily basis (Days 1 through 21). Allopurinol will be administered at dose of 300 mg/day on a daily basis (Days 1 through 21). Irinotecan will be given at 90 mg/m^2 on Days 1 and 8. Cycles are 21 days.
Group III: Phase I Dose Level 1: MMF + Irinotecan + AllopurinolExperimental Treatment3 Interventions
-Mycophenolate mofetil (MMF) will be administered at a dose of 1 g TID (3 g/day) on a daily basis (Days 1 through 21). Allopurinol will be administered at dose of 300 mg/day on a daily basis (Days 1 through 21). Irinotecan will be given at 100 mg/m^2 on Days 1 and 8. Cycles are 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Allopurinol
1999
Completed Phase 4
~6150
Irinotecan
2017
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,944 Previous Clinical Trials
2,304,457 Total Patients Enrolled
Siddhartha Devarakonda, MBBS, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
24 Total Patients Enrolled
Daniel Morgensztern, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
86 Total Patients Enrolled

Media Library

Irinotecan (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05049863 — Phase 1 & 2
Small Cell Lung Cancer Research Study Groups: Phase I Dose Level 1a: MMF + Irinotecan + Allopurinol, Phase I Dose Level 1: MMF + Irinotecan + Allopurinol, Phase II: MMF + Irinotecan + Allopurinol
Small Cell Lung Cancer Clinical Trial 2023: Irinotecan Highlights & Side Effects. Trial Name: NCT05049863 — Phase 1 & 2
Irinotecan (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05049863 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary health conditions for which Mycophenolate Mofetil is prescribed?

"Mycophenolate Mofetil is widely employed to combat kidney transplant rejection, yet can also be applied in the treatment of colorectal carcinoma, ovarian cancer, and various sarcoma cases."

Answered by AI

Are there any opportunities to join the current clinical trial?

"Clinicaltrials.gov states that this particular research project is no longer enrolling participants, with its initial post dated February 28th 2023 and the latest update from October 26th 2022. Nonetheless, there are 1,971 other clinical trials actively seeking candidates at present."

Answered by AI

What other empirical examinations have been conducted using Mycophenolate Mofetil?

"Presently, 399 clinical trials are investigating the effects of Mycophenolate Mofetil. Of these 399 studies, 72 have advanced to Phase 3 testing. Although most research is being conducted in Philadelphia, Pennsylvania, there are 9493 sites conducting such investigations."

Answered by AI

How many participants are included in this research endeavor?

"Unfortunately, this trial is not open for recruitment at present. It was initially posted on February 28th 2023 and the most recent update occurred October 26th 2022. However, if you are seeking alternative trials, 1572 studies are actively looking for patients suffering from small cell lung carcinoma and 399 trials recruiting participants who take Mycophenolate Mofetil."

Answered by AI
~15 spots leftby Apr 2025