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Clinical Trial: Combination Chemotherapy Plus Infusion of White Blood Cells in Treating Patients With Hematologic Cancer
This study has been completed.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. White blood cells from donors may be able to kill cancer cells in patients who have hematologic cancer that has recurred following bone marrow transplantation.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus infusion of donated white blood cells in treating patients who have hematologic cancer that has recurred after bone marrow transplantation.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| childhood non-Hodgkin's lymphoma Leukemia Lymphoma myelodysplastic and myeloproliferative diseases | Drug: allogeneic lymphocytes Drug: cyclophosphamide Drug: doxorubicin HCl liposome Drug: etoposide Drug: filgrastim Drug: interleukin-2 Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Procedure: interleukin therapy Procedure: leukocyte therapy Procedure: peripheral blood lymphocyte therapy | Phase I |
MedlinePlus related topics: Blood and Blood Disorders; Cancer; Cancer Alternative Therapy; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Doxorubicin HCl Liposome, Etoposide, Cyclophosphamide, and Allogeneic Donor Lymphocyte Infusion With or Without Interleukin-2 After Allogeneic Bone Marrow Transplantation in Patients With Relapsed or Persistent Aggressive Hematologic Malignancies
OBJECTIVES:
- Determine the maximum tolerated dose of doxorubicin HCl liposome when combined with etoposide, cyclophosphamide, and allogeneic donor lymphocyte infusion with or without interleukin-2 after allogeneic bone marrow transplantation in patients with relapsed or persistent aggressive hematologic malignancies.
OUTLINE: This is a partially randomized, dose-escalation study of doxorubicin HCl liposome (LipoDox).
Patients enter 1 of 4 cohorts.
- Cohort 1: Three to six patients receive induction comprising etoposide IV over 1 hour on days 1-3, cyclophosphamide IV over 1-2 hours on day 8, and allogeneic donor lymphocyte infusion on day 10. Filgrastim (G-CSF) is administered subcutaneously (SC) or IV daily beginning on day 10 and continuing until blood counts recover.
- Cohort 2: In the absence of dose-limiting toxicity (DLT) on cohort 1, 3-6 patients receive treatment as in cohort 1 and LipoDox IV over 2 hours on day 1.
- In the absence of DLT on cohort 2, 3-6 patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive treatment as in cohort 1 plus a higher dose of LipoDox IV over 2 hours on day 1.
- Patients receive treatment as in cohort 1 and interleukin-2 (IL-2) SC on days 10-12. If DLT is reached on cohort 2, 3-6 patients receive treatment as in arm II.
- Cohort 4: In the absence of DLT on arms I and II, patients receive treatment as in cohort 1, LipoDox as in arm I, and IL-2 as in arm II. Cohorts of 3-6 patients receive escalating doses of LipoDox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study within 12-18 months.
Eligibility
Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of relapsed or persistent acute leukemia, myelodysplasia, aggressive non-Hodgkin's lymphoma (NHL), or chronic myeloid leukemia in transformed phase (accelerated phase or blast crisis) after allogeneic bone marrow transplantation (BMT)
- Aggressive NHL defined as diffuse mixed, diffuse large cell, diffuse small noncleaved cell, and lymphoblastic histologies
- No active acute graft versus host disease (GVHD) or extensive chronic GVHD
PATIENT CHARACTERISTICS: Age:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- More than 4 weeks
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No severe psychiatric illness or mental deficiencies
PRIOR CONCURRENT THERAPY: Biologic therapy:
- See Disease Characteristics
- At least 6 months since prior allogeneic BMT
- No other concurrent interleukin-2
- No other concurrent immunomodulatory medication (e.g., interferon)
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent steroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent immunosuppressive medication (e.g., cyclosporine) for GVHD
Location Information
Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-2410, United States
Ephraim J. Fuchs, MD, Study Chair, Sidney Kimmel Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: June 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003243
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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