Know Cancer

or
forgot password

A Phase I Trial of Combined Chemotherapy and Donor Lymphocyte Infusion for Aggressive Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation


Phase 1
N/A
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

Thank you

Trial Information

A Phase I Trial of Combined Chemotherapy and Donor Lymphocyte Infusion for Aggressive Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation


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.

- Cohort 3: 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.

- Arm II: 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ephraim J. Fuchs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066119, J9743

NCT ID:

NCT00003243

Start Date:

January 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • acute undifferentiated leukemia
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • secondary acute myeloid leukemia
  • previously treated myelodysplastic syndromes
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • childhood chronic myelogenous leukemia
  • atypical chronic myeloid leukemia
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • childhood myelodysplastic syndromes
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410