Study on Vincristine and Temozolomide Combined with PEN-866 for Adolescents and Young Adults with Hard-to-Treat Solid Tumors

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04890093

Provider View

This clinical trial is testing a new combination of drugs, including PEN-866, vincristine, and temozolomide, to see if they can help treat solid tumors in adolescents and young adults whose cancer has returned or did not respond to standard treatments.

Patient Parameters

Program Overview

The study aims to find out if combining the drug PEN-866 with vincristine and temozolomide can effectively treat solid tumors in young people aged 12 to 39. These tumors may have come back after treatment or not responded to standard therapies. Participants will receive these drugs in cycles, with each cycle lasting 21 days, and will be monitored for their health and response to the treatment.

Description

This study is exploring a new treatment for adolescents and young adults with solid tumors that have returned or are resistant to standard treatments. The treatment involves a combination of three drugs: PEN-866, vincristine, and temozolomide. PEN-866 is a new drug that stays in tumor cells longer than in normal cells, potentially making it more effective.

Participants will receive the treatment in cycles, each lasting 21 days, for up to 18 cycles. They will get PEN-866 and vincristine through an IV on Days 1 and 8, and take temozolomide by mouth on Days 1-5 of each cycle. The study will monitor the safety and effectiveness of this combination.

Participants will undergo various tests, including medical history reviews, physical exams, and imaging scans, to ensure they meet the study criteria. They will also complete questionnaires about their health and well-being. After the treatment ends, there will be a follow-up visit, and participants may be contacted for updates on their health.

Eligibility Criteria

Inclusion Criteria

  • Aged between 12 and 39 years.
  • Have a solid tumor, Ewing sarcoma, or rhabdomyosarcoma that has returned or not responded to standard treatments.
  • Must have a tumor sample available for testing.
  • Must have good overall health and organ function.
  • Must have recovered from any side effects of previous treatments.
  • Must agree to use effective birth control during the study and for six months after.
  • Must be willing to have a central venous access line placed if not already in place.

Exclusion Criteria

  • Currently receiving other investigational or anticancer treatments.
  • History of severe allergic reactions to similar drugs.
  • Previously stopped vincristine, temozolomide, or irinotecan due to severe side effects.
  • Have uncontrolled health conditions, such as heart problems or high blood pressure.
  • Pregnant or planning to become pregnant.
  • Have had major surgery within 28 days before starting the study.
  • Have a specific genetic condition (UGT1A1 28/28 genotype) that affects drug metabolism.

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