Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
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Purpose
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and peripheral stem cell transplantation with biological therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy with sargramostim, interleukin-2, and interferon alfa following chemotherapy and peripheral stem cell transplantation in treating patients who have cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor |
Biological: aldesleukin Biological: recombinant interferon alfa Biological: sargramostim |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 1998 |
| Study Completion Date: | March 2000 |
OBJECTIVES:
- Determine the feasibility of therapy with sargramostim (GM-CSF), interleukin-2 and interferon alfa following high dose chemotherapy and autologous stem cell rescue in patients with high risk cancer.
- Determine the effect of this regimen on long-term leukocyte and platelet recovery following high dose chemotherapy and stem cell rescue in these patients.
- Determine the cellular response to this regimen in these patients.
- Assess progression free and overall survival rates in these patients.
OUTLINE: This is a dose escalation study of interleukin-2 and interferon alfa.
Beginning 14 days after the autologous stem cell transplant, patients receive daily subcutaneous injections of sargramostim (GM-CSF) on days 1-7 and daily intravenous interleukin-2 on days 3-7, followed by 1 week of rest. Patients then receive a subcutaneous injection of interferon alfa three times a week for 3 weeks followed by one more week of rest. Treatment is repeated for four courses.
Cohorts of 10 patients each receive escalating doses of interleukin-2 and interferon alfa until a maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 3 of 10 patients experience dose limiting toxicity. Intrapatient dose escalation occurs in courses 2-4, in the absence of dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following cancers and undergoing high dose chemotherapy with autologous stem cell rescue (ASCR):
- Metastatic breast cancer
- Multiple myeloma
- Hodgkin's disease
- Recurrent or refractory low, intermediate, or high grade non-Hodgkin's lymphoma
- Acute myelogenous leukemia beyond first remission
- Acute lymphoblastic leukemia beyond first remission
- Ovarian cancer
- Refractory malignancy and measurable or evaluable disease (at time of ASCR)
Hormone receptor status:
- Not specified
- A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
- Not specified
Menopausal status:
- Not specified
Performance status:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Contacts and Locations| United States, Illinois | |
| Midwestern Regional Medical Center | |
| Zion, Illinois, United States, 60099 | |
| Study Chair: | Anastasios Raptis, MD | Cancer Treatment Centers of America |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003408 History of Changes |
| Other Study ID Numbers: | CDR0000066418, MRMC-CTCA-9801, NCI-V98-1449 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV breast cancer recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma refractory multiple myeloma recurrent childhood rhabdomyosarcoma stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer disseminated neuroblastoma recurrent neuroblastoma recurrent Wilms tumor and other childhood kidney tumors stage I multiple myeloma stage II multiple myeloma |
stage III multiple myeloma recurrent childhood lymphoblastic lymphoma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Neuroblastoma Ovarian Neoplasms |
Trophoblastic Neoplasms Lymphoma, Large-Cell, Immunoblastic Neoplasms, Germ Cell and Embryonal Gestational Trophoblastic Neoplasms Sarcoma Neoplasms by Site Breast Diseases Skin Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Kidney Diseases |
ClinicalTrials.gov processed this record on May 23, 2013