Chemotherapy + Allopurinol + Mycophenolate for Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Daniel Morgensztern, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests if adding MMF and allopurinol to chemotherapy can help patients with relapsed small cell lung cancer by improving their response to treatment and delaying cancer progression.

Research Team

Daniel Morgensztern, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

Ability to understand and willingness to sign an IRB approved written informed consent document

I am 18 years old or older.

My blood tests for bone marrow and organ function are normal.

Exclusion Criteria

I have active hepatitis C.

I have side effects from past treatments, but they are not severe except for tiredness, hormone issues treated with medication, or hair loss.

I do not have active infections and can receive immunosuppressive treatment.

Treatment Details

Interventions

• Allopurinol (Other)
• Irinotecan (Alkylating agents)
• Mycophenolate Mofetil (Other)

Trial Overview 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.

Participant Groups

Group I: Phase II: MMF + Irinotecan + Allopurinol Experimental Treatment 3 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 + Allopurinol Experimental Treatment 3 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 + Allopurinol Experimental Treatment 3 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.

Irinotecan is already approved in Japan, Canada for the following indications:

Approved in Japan as Topotecin for:

• Colorectal cancer
• Small cell lung cancer

Approved in Canada as Irinotecan for:

• Colorectal cancer

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine