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Cytokine-Based Immunotherapy Post-ASCR in High-Risk Cancer
NCT00003408Phase 2
Key facts
- Status
- Completed
- Start
- Apr 1998
- Countries
- 1
- Sponsor
- Cancer Treatment Centers of America
- Modality
- Cytokines & Interferons
- Conditions
- breast cancermultiple myeloma (MM)Hodgkin lymphoma (HL)non-Hodgkin lymphoma (NHL)acute myeloid leukemia (AML)
01
Overview
Phase 2, open-label, single-arm trial of aldesleukin and interferon alfa in breast cancer, multiple myeloma (MM), Hodgkin lymphoma (HL) and 4 more, sponsored by Cancer Treatment Centers of America. Primary endpoints: Maximum Tolerated Dose and Dose Limiting Toxicity. Started Apr 1998; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Dose Escalation Cohorts
Cohorts of 10 patients receiving escalating doses of IL-2 and IFN-alfa alongside GM-CSF.
03
Who it enrols
Patients with high-risk cancers (metastatic breast, multiple myeloma, Hodgkin's disease, non-Hodgkin's lymphoma, acute myelogenous leukemia, acute lymphoblastic leukemia, ovarian cancer, or refractory malignancy) undergoing high-dose chemotherapy with autologous stem cell rescue.
04
Endpoints
Primary
Maximum Tolerated Dose
Dose Limiting Toxicity
Secondary
Long-term leukocyte recovery
Long-term platelet recovery
Cellular response
Progression-Free Survival
Overall Survival
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