Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent or Does Not Respond to Treatment

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as talotrexin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of talotrexin in treating young patients with recurrent solid tumors or leukemia that is recurrent or does not respond to treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of either of the following:

• Recurrent solid tumor

• Histologically confirmed* malignancy at original diagnosis or relapse

• Measurable or evaluable disease

• Lymphoma or primary CNS tumor allowed

• Patients with CNS tumors must be on a stable or decreasing dose of dexamethasone for the past 7 days

• Recurrent or refractory leukemia

• Confirmed relapse, as defined by M3 marrow (25% blasts in bone marrow aspirate or biopsy)

• Active extramedullary disease allowed provided there is no leptomeningeal involvement NOTE: *Histological confirmation not required for intrinsic brain stem tumors

• Bone marrow metastases allowed

• Not refractory to red blood cell or platelet transfusion

• No pleural effusion or significant ascites

• No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists

• No Down syndrome

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) 50-100% (for patients > 10 years of age) OR Lansky PS 50-100% (for patients ≤ 10 years of age)

• Absolute neutrophil count ≥ 1,000/mm³ (for patients with solid tumors without bone marrow involvement)

• Platelet count ≥ 100,000/mm³ (transfusion independent)

• Hemoglobin ≥ 8.0 g/dL

• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine adjusted according to age as follows:

• No greater than 0.6 mg/dL (1 year to 23 months)

• No greater than 0.8 mg/dL (2 to 5 years)

• No greater than 1.0 mg/dL (6 to 9 years)

• No greater than 1.2 mg/dL (10 to 12 years)

• No greater than 1.4 mg/dL (13 years and over [female])

• No greater than 1.5 mg/dL (13 to 15 years [male])

• No greater than 1.7 mg/dL (16 years and over [male])

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT ≤ 110 U/L (ULN is 45 U/L)

• Albumin ≥ 2 g/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infection

• No known condition that, in the opinion of the investigator, would preclude study compliance

PRIOR CONCURRENT THERAPY:

• Recovered from all prior treatment-related toxicity

• At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea) (for patients with solid tumors)

• At least 24 hours since prior cytoreduction therapy initiated with hydroxyurea (for patients with leukemia)

• At least 2 weeks since prior local palliative radiotherapy (small port)

• At least 6 months since prior total-body irradiation (TBI), craniospinal radiotherapy, or ≥ 50% radiotherapy to the pelvis

• At least 6 weeks since prior substantial bone marrow radiotherapy

• At least 3 months since prior stem cell transplant or rescue without TBI

• No evidence of active graft-versus-host disease

• At least 7 days since prior growth factor therapy

• At least 7 days since prior biological therapy

• No nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, penicillins, sulfa drugs (bactrim, septra), ciprofloxacin, tetracycline, thiazide diuretics, or probenecid within 2 days prior to, during, or within 5 days after treatment with talotrexin

• No long-acting NSAIDs (e.g., nabumetone, naproxen, oxaprozin, piroxicam) within 5 days prior to, during, or within 5 days after treatment with talotrexin

• No concurrent investigational drugs

• No concurrent anticancer agents or therapy (e.g., chemotherapy, radiotherapy, immunotherapy, or biologic therapy)