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| ID | Type | Description | Link |
|---|---|---|---|
| 37-7109-2007-001 | Other Grant/Funding Number | Cattleman's Fund | |
| GENITOPE-IND-8294 | Other Grant/Funding Number | Genitope Corporation |
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Genitope suspend drug development by decision made by the FDA March 6, 2008.
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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.
OBJECTIVES:
OUTLINE: Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Patients 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.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous tumor cell vaccine | Biological |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Humoral and Cellular Immune Response | evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Idiotype Vaccine | To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting | At each immunization and at study completion |
| Toxicity of Idiotype Vaccine |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Julie M Vose, MD | University of Nebraska | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaccine Therapy | vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaccine Therapy | vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Humoral and Cellular Immune Response | evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation | NO formal analysis was completed as this trial was halted prematurely. Thirty patients were to be enrolled in the protocol so that 15 patients would be evaluable at the end of the immunization process. Of the 19 patients enrolled on the trial, only 12 went on to complete the vaccine series. | Posted | 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 |
|
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No serious adverse events were observed. No other (non-serious) adverse event were observed within the reporting threshold.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaccine Therapy | vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF |
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The Sponsor Genitope suspend development of MyVax in light of the decision made by the FDA March 6, 2008, therefore this trial was halted prematurely leaving insufficient data to analyze.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan Ludwig, Regulatory Coordinator | University of Nebraska Medical Center Division of Oncology/Hematology | 402-559-8071 | bmludwig@unmc.edu |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C573235 | FANG vaccine |
| C032808 | keyhole-limpet hemocyanin |
| C081222 | sargramostim |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| keyhole limpet hemocyanin |
| Biological |
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| sargramostim | Biological |
|
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| adjuvant therapy | Procedure |
|
To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
| At each immunization and at study completion |
| Changes in Quantitative Bcl-2 | To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines. | 1 year post transplant evaluation and then annually until disease progression |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| Secondary | Safety of Idiotype Vaccine | To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting | The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged. | Posted | At each immunization and at study completion |
|
|
| Secondary | Toxicity of Idiotype Vaccine | To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting | The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged. | Posted | At each immunization and at study completion |
|
|
| Secondary | Changes in Quantitative Bcl-2 | To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines. | The study was terminated early and was not analyzed. At this time, the evaluation of this data is unknown as it has been purged. | Posted | 1 year post transplant evaluation and then annually until disease progression |
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|
| 0 |
| 19 |
| 0 |
| 19 |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |