CAMPFIRE: Study of Ramucirumab in Children and Young Adults with Desmoplastic Small Round Cell Tumor

Sponsor: Eli Lilly and Company

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04145349

Provider View

This study is testing the safety and effectiveness of the drug ramucirumab, combined with other chemotherapy, for treating a rare cancer called desmoplastic small round cell tumor (DSRCT) in children and young adults. Participation could last 12 months or more, depending on individual response.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective ramucirumab is when used with other chemotherapy drugs to treat children and young adults with desmoplastic small round cell tumor (DSRCT) that has come back or not responded to previous treatments. This trial is part of a larger program aimed at speeding up the development of new cancer treatments for young patients. Participants may be involved in the study for a year or longer, depending on how they and their tumors respond to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have stopped all previous cancer treatments at least 7 days before starting this study and recovered from any side effects.
  • Must have DSRCT that has come back, not responded, or returned after treatment.
  • Must have measurable disease based on specific medical criteria.
  • Must have had at least one previous treatment for cancer.
  • Must not be eligible for surgery to remove the tumor.
  • Must have good heart function and controlled blood pressure.
  • Must have adequate blood cell counts and organ function.
  • Must not be pregnant and agree to use effective birth control during and after the study.

Exclusion Criteria

  • Cannot have severe or uncontrolled medical or psychiatric conditions.
  • Cannot have active infections requiring treatment.
  • Cannot have had a bone marrow or organ transplant.
  • Cannot have had major surgery or significant injury within 28 days before starting the study.
  • Cannot have a history of significant bleeding or blood clots.
  • Cannot have serious heart conditions or recent heart attacks.
  • Cannot have certain liver conditions or severe liver disease.
  • Cannot have bowel obstructions or severe digestive issues.
  • Cannot have urinary blockages or severe bladder issues.
  • Cannot have cancer that has spread to the brain.

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