Chemotherapy in Patients With Relapsed Small Cell Lung Cancer in Combination With Allopurinol and MycoPhenolate (CLAMP Trial)

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05049863
Phase
PHASE1
Status
Terminated

Conditions

  • Small Cell Lung Carcinoma
  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mycophenolate Mofetil — DRUG
    Mycophenolate mofetil is commercially available.
  • Allopurinol — DRUG
    Allopurinol is commercially available.
  • Irinotecan — DRUG
    Irinotecan is commercially available.

Study Details

The hypothesis is that the addition of mycophenolate mofetil (MMF) and allopurinol to chemotherapy in patients with relapsed small cell lung cancer (SCLC) will be safely tolerated and improve outcomes, as measured by response rate and progression-free survival in patients compared to other single agent chemotherapy drugs used in historical controls.

Key Dates

Start date
Feb 27, 2023
Status verified
Dec 2024
Primary completion
Nov 17, 2024
Completion
Nov 17, 2024

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose Level 1a: MMF + Irinotecan + Allopurinol
    -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.
  • Experimental: Phase I Dose Level 1: MMF + Irinotecan + Allopurinol
    -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.
  • Experimental: Phase II: MMF + Irinotecan + Allopurinol
    -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.

Primary Outcome Measure

Number of study treatment related adverse events as measured by NCI-CTCAE v 5.0 (Phase I only) [ Time Frame: Through 30 days after completion of treatment (estimated to be 5 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By research site
Washington University School of Medicine· St Louis, MO

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