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A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies


Phase 2
N/A
55 Years
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies


OBJECTIVES:

- Determine non-hematologic toxic effects of high-dose cytarabine and high-dose
mitoxantrone in patients with recurrent or refractory leukemia or lymphoma.

- Determine the in vitro T/NK lymphocyte proliferative responses to patient's
leukemia/lymphoma cells before and after treatment with this regimen.

OUTLINE: Patients receive high-dose cytarabine IV over 1 hour on days 1-5 and high-dose
mitoxantrone IV over 15-30 minutes on day 5. Patients also receive sargramostim (GM-CSF)
subcutaneously beginning on day 14 and continuing until blood counts recover.

Patients who achieve at least stable disease or a response may receive a second course
beginning at least 14 days after the first course is completed.

Patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within
approximately 2-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- One of the following must be present:

- Histologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia

- More than 5% blasts in the bone marrow or peripheral blood unrelated to
recovery of normal hematopoiesis from prior chemotherapy

- Failed at least 1 attempt at induction chemotherapy

- Diagnosis of non-Hodgkin's lymphoma or Hodgkin's lymphoma

- Refractory or relapsed after at least 1 regimen of standard chemotherapy

- Diagnosis of chronic myelogenous leukemia in accelerated phase or blast crisis

- Received at least 1 myelotoxic chemotherapy regimen

- Active CNS involvement allowed

PATIENT CHARACTERISTICS:

Age

- 55 and under

Performance status

- ECOG 0-2

Life expectancy

- At least 5 weeks

Hematopoietic

- Lymphoma patients:

- WBC at least 2,000/mm^3*

- Platelet count at least 20,000/mm^3* NOTE: *Unless due to bone marrow
involvement or disease process

Hepatic

- Bilirubin no greater than 3 times normal*

- AST/ALT no greater than 3 times normal*

- Alkaline phosphatase no greater than 3 times normal*

- No severe liver failure NOTE: *Unless related to leukemia

Renal

- Creatinine clearance greater than 50 mL/min

- No severe renal failure

Cardiovascular

- LVEF at least 45% by MUGA

Pulmonary

- DLCO at least 60% of predicted

Other

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No psychiatric illness that would preclude informed consent

- No medical illness or other condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- At least 24 hours since prior hydroxyurea

- At least 1 week since other prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- Recovered from prior therapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event free survival at day 14 (myeloid engraftment)

Outcome Time Frame:

day 14

Safety Issue:

No

Principal Investigator

Mary J. Laughlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU5Y01

NCT ID:

NCT00047021

Start Date:

November 2001

Completion Date:

September 2005

Related Keywords:

  • Leukemia
  • Lymphoma
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • childhood chronic myelogenous leukemia
  • atypical chronic myeloid leukemia
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Leukemia
  • Lymphoma

Name

Location
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065