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Combination Chemotherapy Plus Infusion of White Blood Cells in Treating Patients With Hematologic Cancer - Article


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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.

Sponsored by: Sidney Kimmel Cancer Center
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

OBJECTIVES:

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:

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:


Location Information


Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States

Study chairs or principal investigators

Ephraim J. Fuchs, MD,  Study Chair,  Sidney Kimmel Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066119; JHOC-97112101; NCI-V98-1387
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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