Status:
WITHDRAWN
Talotrexin in Treating Young Patients With Recurrent Solid Tumors or Leukemia That is Recurrent or Does Not Respond to Treatment
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Leukemia
Eligibility:
All Genders
1-21 years
Phase:
PHASE1
Brief 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 phas...
Detailed Description
OBJECTIVES: Primary * Estimate the maximum tolerated dose (MTD) and recommended phase II dose of talotrexin in younger patients with recurrent solid tumors or recurrent or refractory leukemia. * Det...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00458744
Start Date
February 1 2007
Last Update
August 8 2014
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