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Mycophenolate Mofetil for Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MOSmall Cell Lung Cancer+1 MoreMycophenolate Mofetil - Drug
Eligibility
18+
All Sexes
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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.

Eligible Conditions
  • Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Allogeneic HSCT

Study Objectives

7 Primary · 4 Secondary · Reporting Duration: Through 6 months after completion of treatment (estimated to be 10 months)

Month 10
Maximum tolerated dose (MTD)/Recommended phase II dose (RP2D) (Phase I only)
Number of DLTs in Phase I patients
Recommended phase II dose (RP2D) (Phase I only)
Month 5
Number of study treatment related adverse events as measured by NCI-CTCAE v 5.0 (Phase I only)
Month 10
Overall survival (OS) (Phase II and phase I patients who receive the MTD)
Overall survival (OS) (Phase II only)
Progression-free survival (PFS) (Phase II and phase I patients who receive the MTD)
Progression-free survival (PFS) (Phase II only)
Month 4
Number of discontinuations due to treatment related adverse events (Phase I only)
Overall response rate (ORR) (Phase II and phase I patients who receive the MTD)
Overall response rate (ORR) (Phase II only)

Trial Safety

Safety Progress

1 of 3

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1
BAY2927088_formulation B_1
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Side Effects for

Arm II (TBI, Transplant, GVHD Prophylaxis)
23%Blood/Bone marrow
11%Cardiovascular
9%Pulmonary
7%Hepatic
7%Gastrointestinal
5%Graft versus host disease with infection and organ failure
2%respiratory failure
2%Hemorrhage
2%subdural hematoma
2%thrombosis
2%Dermatology/Skin
2%Renal/Genitourinary
2%Metabolic/Laboratory
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT00075478) in the Arm II (TBI, Transplant, GVHD Prophylaxis) ARM group. Side effects include: Blood/Bone marrow with 23%, Cardiovascular with 11%, Pulmonary with 9%, Hepatic with 7%, Gastrointestinal with 7%.

Trial Design

3 Treatment Groups

Phase I Dose Level 0: MMF + Irinotecan + Allopurinol
1 of 3
Phase I Dose Level 1: MMF + Irinotecan + Allopurinol
1 of 3
Phase II: MMF + Irinotecan + Allopurinol
1 of 3

Experimental Treatment

36 Total Participants · 3 Treatment Groups

Primary Treatment: Mycophenolate Mofetil · No Placebo Group · Phase 1 & 2

Phase I Dose Level 0: MMF + Irinotecan + AllopurinolExperimental Group · 3 Interventions: Irinotecan, Mycophenolate Mofetil, Allopurinol · Intervention Types: Drug, Drug, Drug
Phase I Dose Level 1: MMF + Irinotecan + AllopurinolExperimental Group · 3 Interventions: Irinotecan, Mycophenolate Mofetil, Allopurinol · Intervention Types: Drug, Drug, Drug
Phase II: MMF + Irinotecan + AllopurinolExperimental Group · 3 Interventions: Irinotecan, Mycophenolate Mofetil, Allopurinol · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Mycophenolate mofetil
FDA approved
Allopurinol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 6 months after completion of treatment (estimated to be 10 months)

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,826 Previous Clinical Trials
2,284,361 Total Patients Enrolled
Daniel Morgensztern, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
86 Total Patients Enrolled
Siddhartha Devarakonda, MBBS, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
22 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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