Multiple Drug Therapies for Cancer in Children and Young Adults
(CAMPFIRE Trial)
Recruiting in Palo Alto (17 mi)
+65 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Eli Lilly and Company
Disqualifiers: Severe disease, Active infections, Transplant, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial tests new cancer drugs to see if they help patients and how long the benefits last. It focuses on different types of cancer and adds new studies as new drugs are developed.
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 trial. It does not specify about other medications, so you may need to discuss this with the trial team.
What data supports the effectiveness of the drug combination used in the clinical trial for cancer in children and young adults?
Research shows that the combination of vinorelbine and cyclophosphamide has been effective in treating relapsed or refractory solid tumors in children and young adults, with good tolerance and efficacy in rhabdomyosarcoma. Additionally, the combination of vincristine, irinotecan, and temozolomide has been effective for relapsed and refractory neuroblastoma, suggesting potential benefits of these drugs in pediatric cancers.
12345Is the combination of vinorelbine and cyclophosphamide safe for children and young adults?
The combination of vinorelbine and cyclophosphamide has been studied in children and young adults with relapsed or refractory solid tumors, showing a good tolerance profile, meaning it was generally safe for use in this group.
34678What makes the drug combination of Abemaciclib, Cyclophosphamide, Docetaxel, Gemcitabine, Irinotecan, Ramucirumab, Temozolomide, and Vinorelbine unique for treating cancer in children and young adults?
This drug combination is unique because it combines multiple agents that have shown effectiveness in treating various solid tumors in children and young adults, potentially offering a synergistic effect. The inclusion of drugs like Abemaciclib, which targets specific cancer cell growth pathways, alongside traditional chemotherapy agents, aims to enhance treatment efficacy and overcome resistance seen in relapsed or refractory cases.
357910Eligibility Criteria
This trial is for children and young adults with cancer who have a performance score of at least 50, measurable disease, and adequate organ function. They must not have received cancer treatment or investigational agents in the last 7 days. Participants must agree to use effective contraception.Inclusion Criteria
I agree to use effective birth control during and for 3 months after the trial.
My cancer can be measured or evaluated using standard methods.
My blood counts and organ functions are within normal ranges.
+3 more
Exclusion Criteria
I have had, or plan to have, a surgery or similar procedure.
Participants who have had allogeneic bone marrow or solid organ transplant
I am currently being treated for an active infection.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive treatment with various drug combinations in cycles specific to their cancer type
21-28 days per cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Extension
Participants may continue treatment as long as they benefit from it
Participant Groups
The master protocol oversees multiple trials testing drugs like Cyclophosphamide, Gemcitabine, and others against various cancers in youths. It aims to streamline research by using a common framework that adapts as new treatments are introduced.
6Treatment groups
Experimental Treatment
Active Control
Group I: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)Experimental Treatment3 Interventions
Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
Group II: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)Experimental Treatment3 Interventions
Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).
Group III: Abemaciclib + Irinotecan + Temozolomide (ES ISA)Experimental Treatment3 Interventions
Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
Group IV: Cyclophosphamide + Vinorelbine (DSRCT ISA)Active Control2 Interventions
Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
Group V: Gemcitabine + Docetaxel (SS ISA)Active Control2 Interventions
Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
Group VI: Irinotecan + Temozolomide (ES ISA)Active Control2 Interventions
Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.
Abemaciclib is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Verzenio for:
- Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
🇪🇺 Approved in European Union as Verzenio for:
- HR+, HER2- advanced or metastatic breast cancer
- HR+, HER2- node-positive early breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Healthcare of Atlanta, Inc. at EglestonAtlanta, GA
Riley Hospital for ChildrenIndianapolis, IN
C.S. Mott Children's HospitalAnn Arbor, MI
Washington University Medical SchoolSaint Louis, MO
More Trial Locations
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Who Is Running the Clinical Trial?
Eli Lilly and CompanyLead Sponsor
References
Combination chemotherapy with vinorelbine (Navelbine) and mitoxantrone for metastatic breast cancer: a review. [2018]Trials establishing the safety and efficacy of single-agent vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) as first- and second-line chemotherapy for metastatic breast cancer led to testing of the combination of vinorelbine and mitoxantrone. Three phase II clinical trials in Europe and South America, and one phase I trial in the United States have studied the effects of this combination on advanced breast cancer. In the two phase II trials that used vinorelbine and mitoxantrone only, response rates were 56% for patients who received the combination as first-line therapy and 36% for those who were anthracycline resistant. A third phase II trial looked at the effects of a combination of mitoxantrone and vinorelbine plus ifosfamide with mesna in patients who had failed at least two prior chemotherapy regimens; a 41% response rate was noted. In the phase I trial, the combination of vinorelbine and mitoxantrone with prophylactic granulocyte colony-stimulating factors was explored. Further trials are needed to study the combination of vinorelbine and mitoxantrone.
Vincristine, Irinotecan, and Temozolomide in Patients With Relapsed/Refractory Neuroblastoma. [2022]The combination of irinotecan, temozolomide and vincristine has been proposed as an effective salvage regimen for some pediatric malignancies. Thus, we sought to evaluate this combination for patients with relapsed and refractory neuroblastoma (NB).
Phase II study of vinorelbine and continuous low doses cyclophosphamide in children and young adults with a relapsed or refractory malignant solid tumour: good tolerance profile and efficacy in rhabdomyosarcoma--a report from the Société Française des Cancers et leucémies de l'Enfant et de l'adolescent (SFCE). [2018]This phase II study evaluated efficacy, safety and pharmacokinetics (PK) profile of combination intravenous vinorelbine (VNL) and continuous low doses oral cyclophosphamide (CPM) combination in children and young adults with a recurrent or refractory solid tumour.
Impact of pharmacogenetics on variability in exposure to oral vinorelbine among pediatric patients: a model-based population pharmacokinetic analysis. [2022]Better understanding of pharmacokinetics of oral vinorelbine (VNR) in children would help predicting drug exposure and, beyond, clinical outcome. Here, we have characterized the population pharmacokinetics of oral VNR and studied the factors likely to explain the variability observed in VNR exposure among young patients.
An overview of current results with the vincristine-irinotecan-temozolomide combination with or without bevacizumab in pediatric, adolescence and adult solid tumors. [2021]Malignant tumors in young patients present a significant therapeutic challenge for physicians, partially due to their rarity and a relative lack of data, at least compared to adult tumors. As a result, there is an urgent need to explore new possible therapeutic regimens, either by introducing novel agents or by exploring combinations of existing agents. Vincristine, Temozolomide and Irinotecan are chemotherapeutic drugs which have emerged over the last six decades as monotherapy or as part of therapeutic regimens in various solid tumors. Combining these agents can yield strong synergistic effects, as suggested by preclinical data and results from clinical trials. Furthermore, adding novel molecules, such as anti-VEGF factor Bevacizumab to the aforementioned regimens, has shown efficacy in a limited number of trials, which are thoroughly analyzed throughout this review. Data presented throughout this paper suggest that VIT(b) regimen should be further explored in solid tumors in pediatric and adolescent patients.
Pharmacokinetics of oral vinorelbine in French children with recurrent or progressive primary low-grade glioma. [2022]There is a crucial need for pharmacokinetic (PK) data on oral vinorelbine (VNR) in the paediatric population. The aim of this work was to assess the PK profile of orally administered VNR in children with recurrent/progressive primary low-grade glioma (LGG).
Pilot study of vincristine, oral irinotecan, and temozolomide (VOIT regimen) combined with bevacizumab in pediatric patients with recurrent solid tumors or brain tumors. [2020]The combination of vincristine, oral irinotecan, and temozolomide (VOIT regimen) has shown antitumor activity in a pediatric Phase I trial. To further potentiate synergy, we assessed the safety and feasibility of adding bevacizumab to VOIT for children and young adults with recurrent tumors.
Phase I evaluation of oral and intravenous vinorelbine in pediatric cancer patients: a report from the Children's Oncology Group. [2018]Vinorelbine (Navelbine) is an orally absorbable Vinca with broad antitumor activity. It differs from other Vinca in that it is structurally modified on the catharanthine nucleus and has differential actions on tubulin that render it less neurotoxic than other compounds in this class. We conducted a phase I study of vinorelbine given the activity of Vinca alkaloids in many pediatric tumors.
Irinotecan-temozolomide with temsirolimus or dinutuximab in children with refractory or relapsed neuroblastoma (COG ANBL1221): an open-label, randomised, phase 2 trial. [2022]Outcomes for children with relapsed and refractory neuroblastoma are dismal. The combination of irinotecan and temozolomide has activity in these patients, and its acceptable toxicity profile makes it an excellent backbone for study of new agents. We aimed to test the addition of temsirolimus or dinutuximab to irinotecan-temozolomide in patients with relapsed or refractory neuroblastoma.
Phase I trial of two schedules of vincristine, oral irinotecan, and temozolomide (VOIT) for children with relapsed or refractory solid tumors: a Children's Oncology Group phase I consortium study. [2021]In preclinical models, temozolomide, and vincristine are additive or synergistic with irinotecan. We examined this three-drug combination in children with relapsed solid tumors. Patients received orally administered irinotecan together with temozolomide and vincristine on two different schedules, using cefixime to reduce irinotecan-associated diarrhea.