Lymphoma Clinical Trial
Official title:
A Phase I Study Of Talotrexin (PT-523) In Children And Adolescents With Recurrent Solid Tumors Or Recurrent/Refractory Leukemias
Verified date | August 2014 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 21 Years |
Eligibility |
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) |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of talotrexin | Yes | ||
Primary | Toxicity | Yes | ||
Secondary | Antitumor activity | No | ||
Secondary | Tolerability | Yes |
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