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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003408
Recruitment Status : Completed
First Posted : May 23, 2003
Last Update Posted : March 26, 2013
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
May 23, 2003
March 26, 2013
April 1998
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Complete list of historical versions of study NCT00003408 on Archive Site
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Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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March 2000
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  • 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.



  • Not specified

Menopausal status:

  • Not specified

Performance status:

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Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


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Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United States
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Cancer Treatment Centers of America
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Study Chair: Anastasios Raptis, MD Cancer Treatment Centers of America
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP