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Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia


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

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Trial Information

Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia


OBJECTIVES:

- Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in
children with recurrent acute lymphoblastic leukemia, recurrent osteogenic sarcoma, or
refractory non-Hodgkin's lymphoma resistant to methotrexate.

- Evaluate the toxicity of this treatment regimen in this patient population.

OUTLINE: Patients are stratified according to disease (acute lymphocytic leukemia,
non-Hodgkin's lymphoma vs osteogenic sarcoma).

Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral
leucovorin calcium every 12 hours on days 1-24. Treatment repeats every 4 weeks. Patients
with stable or responsive disease may receive up to 4 courses of therapy.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologic evidence of one of the following malignancies that has failed conventional
therapy:

- Acute lymphoblastic leukemia

- Non-Hodgkin's lymphoma with bone marrow involvement

- Osteogenic sarcoma

- In vitro transport resistance to methotrexate demonstrated by bone marrow aspirate
assay

PATIENT CHARACTERISTICS:

Age:

- 21 and under at diagnosis

Performance status:

- ECOG 0-2

Life expectancy:

- At least 8 weeks

Hematopoietic:

- Granulocytopenia allowed with bone marrow involvement

- Thrombocytopenia allowed with bone marrow involvement

- Anemia allowed with bone marrow involvement

Hepatic:

- (unless due to disease)

- Bilirubin no greater than 2.0 mg/dL

- AST no greater than 100

Renal:

- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Other:

- No other serious medical illness

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior bone marrow transplantation allowed

Chemotherapy:

- At least 1 week since prior intrathecal treatment

- At least 2 weeks since prior systemic chemotherapy and recovered

- At least 10 days for rapidly proliferating leukemia (i.e., WBC greater than
50,000)

- No concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Prior radiotherapy allowed and recovered

- No concurrent radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Tanya Trippett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

95-093

NCT ID:

NCT00002738

Start Date:

January 1996

Completion Date:

June 2006

Related Keywords:

  • Leukemia
  • Lymphoma
  • Sarcoma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood lymphoblastic lymphoma
  • recurrent osteosarcoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Osteosarcoma
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021