Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003408
First received: November 1, 1999
Last updated: March 25, 2013
Last verified: April 2003
  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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes Leukemia, Myeloid Chronic Myeloid Leukemia Malignant Mesenchymal Tumor Soft Tissue Sarcoma Neuroblastoma Multiple Myeloma Lymphosarcoma Mantle Cell Lymphoma B-cell Lymphomas Ovarian Cancer Ovarian Epithelial Cancer Ovarian Germ Cell Tumor Burkitt Lymphoma Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Acute Lymphoblastic Leukemia, Childhood Kidney Cancer Renal Cancer Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Follicular Lymphoma Lymphoma, Large-cell Acute Myeloid Leukemia, Adult Lymphoma, Small Cleaved-cell, Diffuse Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Hodgkin Lymphoma Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Mycosis Fungoides Sezary Syndrome Cutaneous T-cell Lymphoma Myelofibrosis Acute Myeloid Leukemia, Childhood Small Non-cleaved Cell Lymphoma Hodgkin Lymphoma, Childhood Hairy Cell Leukemia Chronic Myeloproliferative Disorders Wilms' Tumor Gestational Trophoblastic Tumor Testicular Cancer Acute Promyelocytic Leukemia Choriocarcinoma Yolk Sac Tumor Embryonal Carcinoma Polyembryoma Seminoma Anaplastic Plasmacytoma Hydatidiform Mole Neuroepithelioma
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: April 1998
Study Completion Date: March 2000
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003408

Locations
United States, Illinois
Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
Sponsors and Collaborators
Cancer Treatment Centers of America
Investigators
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):
recurrent Wilms tumor and other childhood kidney tumors
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
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:
Kidney Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Lymphoma
Leukemia
Syndrome
Breast Neoplasms
Neoplasms
Ovarian Neoplasms
Neuroblastoma
Neoplasms, Germ Cell and Embryonal
Carcinoma, Renal Cell
Plasmacytoma
Testicular Neoplasms
Myeloproliferative Disorders
Gestational Trophoblastic Disease
Trophoblastic Neoplasms
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 18, 2014