Ramucirumab for Desmoplastic Small Round Cell Tumor
Trial Summary
What is the purpose of this trial?
This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
Will I have to stop taking my current medications?
The trial requires participants to stop all previous cancer treatments or investigational agents at least 7 days before starting the study treatment. However, it does not specify if you need to stop other non-cancer medications, so it's best to discuss your current medications with the trial team.
What evidence supports the effectiveness of the drug combination including Ramucirumab for treating desmoplastic small round cell tumor?
Research shows that a combination of vinorelbine and cyclophosphamide has been effective in some patients with desmoplastic small round cell tumor, suggesting potential benefits of similar drug combinations. Additionally, a regimen including vinorelbine, cyclophosphamide, and temsirolimus showed partial responses in patients, indicating that these drugs can be effective in treating this type of tumor.12345
Is vinorelbine generally safe for humans?
What makes the drug combination of Cyclophosphamide, Ramucirumab, and Vinorelbine unique for treating Desmoplastic Small Round Cell Tumor?
This drug combination is unique because it includes Ramucirumab, which is a targeted therapy that works by blocking blood vessel growth in tumors, potentially enhancing the effectiveness of traditional chemotherapy drugs like Cyclophosphamide and Vinorelbine. This approach may offer a novel treatment option for Desmoplastic Small Round Cell Tumor, a condition with limited standard therapies.26101112
Research Team
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Principal Investigator
Eli Lilly and Company
Eligibility Criteria
This trial is for children and young adults with relapsed, recurrent, or refractory Desmoplastic Small Round Cell Tumor (DSRCT). Participants must have tried at least one systemic treatment before, not be eligible for surgery, and have adequate organ function. They should not have severe infections, recent significant bleeding events or thrombosis, uncontrolled hypertension, certain heart conditions or a history of severe liver disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ramucirumab in combination with other chemotherapy drugs, including cyclophosphamide and vinorelbine, for up to 10 cycles of 28 days each
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term if beneficial
Treatment Details
Interventions
- Cyclophosphamide
- Ramucirumab
- Vinorelbine
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University