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Home > "V" Clinical Trials Conditions > Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma  Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
For Condition: recurrent grade 3 follicular lymphoma,recurrent grade 1 follicular lymphoma,recurrent grade 2 follicular lymphoma
Status: Recruiting
Sponsor(s): University of Nebraska ,
Synopsis: 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.
Details: OBJECTIVES: - Determine the humoral and cellular immune responses in patients with follicular non-Hodgkin's lymphoma treated with autologous lymphoma-derived idiotype vaccine with keyhole limpet hemocyanin plus sargramostim (GM-CSF). - Determine the safety and toxicity of this regimen in these patients in the post-transplant setting. - Determine the changes in quantitative bcl-2 in the blood and bone marrow of these patients before and at various times after the series of idiotype vaccines. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy - Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation - Minimal disease state at day 100 to 6 months post-transplantation - Lymph nodes smaller than 2 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 - Must have adequate circulating lymphoma cells PATIENT CHARACTERISTICS: Age: - Over 19 Performance status: - Karnofsky greater than 70% Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - Absolute neutrophil count greater than 1,000/mm^3* - CD4+ count greater than 200/microliter* NOTE: *No restrictions if study vaccine administered at 6 months after transplantation Hepatic: - Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement) - SGOT and SGPT less than 2 times normal (unless due to lymphomatous involvement) Renal: - Creatinine no greater than 2.0 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JulieVose, Study Chair, University of Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Julie Vose 402-559-3848
Additional Information:
Study ID Numbers: CDR0000068307; UNMC-260-00,GENITOPE-IND-8294
Study Start Date:
Record last reviewed: April 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006478
Other Recurrent Grade 3 Follicular Lymphoma Studies:
1. FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma
2. Combination Chemotherapy and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
3. Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
4. Biological Therapy Following Chemotherapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
5. Rituximab With or Without Interleukin-12 in Treating Patients With Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade 3 follicular lymphoma Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
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