Clinical trial · Interventional
Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma
Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Genitope suspend drug development by decision made by the FDA March 6, 2008.
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Vaccine therapy may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| autologous tumor cell vaccine | Biological | — | UNRESOLVED |
| keyhole limpet hemocyanin | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation
- description
- Phase II trial to study the effectiveness, safety \& toxicity of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma. Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Participants receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.
- interventionNames
- Biological: autologous tumor cell vaccine
- Biological: keyhole limpet hemocyanin
- Biological: sargramostim
- Procedure: adjuvant therapy
Primary outcomes (1)
- measure
- Number of Participants With Humoral and Cellular Immune Response
- timeFrame
- immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Over 19 years of age * Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy * Minimal disease state at day 100 to 6 months post-transplantatio * Lymph nodes smaller than 2 centimeters (cm) * Less than 20% bone marrow involvement with lymphoma * Uncertain complete remission, defined by greater than 75% reduction in the size of the pre-transplantation mass not representing active disease * Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy o Must have adequate circulating lymphoma cells * Karnofsky greater than 70% * Absolute neutrophil count greater than 1,000/mm\^3 (No restrictions if study vaccine administered at 6 months after transplantation) * CD4+ count greater than 200/microliter (No restrictions if study vaccine administered at 6 months after transplantation) * Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement) * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2 times normal (unless due to lymphomatous involvement) * Creatinine no greater than 2.0 mg/dL * Fertile patients must use effective contraception during and for 6 months after study participation Exclusion Criteria: * Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation * Not pregnant or nursing/negative pregnancy test
References
Publications (0)
Data not yet available