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View Clinical Trial (Medical Research Study)
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Topotecan in Treating Young Patients With Neoplastic Meningitis Due to Leukemia, Lymphoma, or Solid Tumors - NCT00112619-94115 (Clinical Trial 124974)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy124974.aspx
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| City: |
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San Francisco |
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State:
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CA |
| Zip Code: |
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94115 |
| Conditions: |
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Brain and Central Nervous System Tumors - Carcinoma of Unknown Primary - Leukemia - Lymphoma - Metastatic Cancer - Unspecified Childhood Solid Tumor, Protocol Specific |
| Purpose: |
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RATIONALE: Drugs used in chemotherapy, such as topotecan, 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, best way to give, and best dose of
topotecan when given by intraventricular infusion in treating young patients with neoplastic
meningitis due to leukemia, lymphoma, or solid tumors.
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| Study summary: |
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OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of intraventricular topotecan in young
patients with neoplastic meningitis secondary to leukemia, lymphoma, or solid tumors.
- Determine the toxic effects and dose-limiting toxicity of this drug in these patients.
- Determine whether the MTD of this drug is also the pharmacokinetic optimal dose,
defined by the topotecan lactone concentration in the cerebral spinal fluid (CSF), in
these patients.
Secondary
- Determine, preliminarily, the antitumor activity of this drug in these patients.
- Determine the pharmacokinetics of this drug in the CSF of these patients.
- Correlate observed effects of post-treatment central review imaging (if feasible) with
response to this drug in these patients.
OUTLINE: This is a non-randomized, dose-escalation, multicenter study.
- Induction therapy (weeks 1-4): Patients receive topotecan intraventricularly* over 5
minutes on days 1-5 in weeks 1 and 3. Patients then proceed to consolidation therapy in
week 5.
NOTE: *Patients who are willing, receive 1 intralumbar (instead of intraventricular) dose of
topotecan on day 1 of week 3 only.
- Consolidation therapy (weeks 5-10): Patients receive topotecan intraventricularly on
days 1-5 in weeks 5 and 8. Patients then proceed to maintenance therapy in week 11.
- Maintenance therapy (weeks 11-54): Patients receive topotecan intraventricularly on
days 1-5 in weeks 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, and 51.
Cohorts of 3-6 patients receive escalating doses of intraventricular topotecan until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Once the MTD is determined, the cohort is expanded to 25 patients and the MTD is declared
the pharmacokinetic optimal dose provided 23 of 25 patients treated at the MTD achieve the
target pharmacokinetic parameter.
PROJECTED ACCRUAL: A total of 28-49 patients will be accrued for this study within 9-24
months. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Diagnosis of neoplastic meningitis secondary to leukemia, lymphoma (including
AIDS-related lymphoma), or solid tumor (including primary CNS tumors or carcinomas of
unknown primary site), defined by 1 of the following criteria:
- Cerebral spinal fluid (CSF) cell count > 5/μL AND evidence of blast cells on
cytospin or by cytology (for patients with leukemia or lymphoma)
- Presence of tumor cells on cytospin or cytology OR unequivocal presence of
meningeal disease by MRI (for patients with solid tumor)
- No conventional therapy for neoplastic meningitis exists
- Patients with CNS leukemia or lymphoma must be refractory to conventional
therapy, including radiotherapy (i.e., second or greater relapse)
- Patients with CNS leukemia or lymphoma must have had a negative bone marrow
aspiration within the past 2 weeks
- No clinical evidence of obstructive hydrocephalus
- No compartmentalization of CSF flow by radioisotope indium In 111 or technetium Tc 99
DTPA flow study
- No ventriculoperitoneal or ventriculoatrial shunt unless patient is completely
shunt-independent
- No impending spinal cord compression or other CNS involvement (e.g., acute visual
loss secondary to optic nerve involvement) requiring emergent local radiotherapy
PATIENT CHARACTERISTICS:
Age
- 3 to 21
Performance status
- Lansky 60-100% (≤ 16 years of age) OR
- Karnofsky 60-100% (> 16 years of age)
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Calcium ≥ 7 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Sodium 125-150 mmol/L
- Magnesium ≥ 0.7 mmol/L
- Must have or be willing to have an intraventricular access device (i.e., Ommaya
reservoir)
- No uncontrolled infection
- HIV-positive patients with AIDS-related lymphomatous meningitis are eligible
- No other significant uncontrolled systemic medical illness that would preclude study
participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Recovered from prior biologic therapy or immunotherapy
Chemotherapy
- Recovered from prior chemotherapy
- At least 1 week since prior intra-colony stimulating factory (CSF) chemotherapy (2
weeks for liposomal cytarabine)
- At least 3 weeks since prior systemic chemotherapy for leptomeningeal disease
- Concurrent systemic chemotherapy to control systemic disease or bulk CNS disease
allowed provided the systemic chemotherapy is not an investigational agent OR any of
the following:
- High-dose (> 1 g/m^2) methotrexate
- High-dose (> 1 g/m^2) cytarabine
- Fluorouracil
- Capecitabine
- Thiotepa
- Nitrosoureas
- Topotecan
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 8 weeks since prior craniospinal radiotherapy and recovered
- No concurrent CNS radiotherapy
- Concurrent radiotherapy to extra-CNS sites (e.g., painful bone metastases not in
the craniospinal axis) allowed
Surgery
- Not specified
Other
- More than 2 weeks since prior and no other concurrent investigational agents
- No other concurrent intra-CSF or systemic therapy for leptomeningeal disease |
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| Study is available at: |
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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA 94115
United States
Primary Contact:
Clinical Trials Office - UCSF Helen Diller Family Comprehensi
Phone: 877-827-3222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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