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Sponsored by: |
Cambridge Antibody Technology |
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Information provided by: | Cambridge Antibody Technology |
ClinicalTrials.gov Identifier: | NCT00462189 |
RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia(HCL) that has not responded to chemotherapy, surgery or radiation therapy.
PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have hairy cell leukemia (HCL) that has not responded to treatment.
Condition | Intervention | Phase |
---|---|---|
Leukemia Hairy Cell Leukemia HCL |
Drug: Immunotoxin therapy Drug: CAT-8015 Immunotoxin Procedure: Biological therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patient With Relapsed or Refractory Hairy Cell Leukemia (HCL) |
Estimated Enrollment: | 40 |
Study Start Date: | April 2007 |
OUTLINE: Patients receive CAT-8015 IV over 30 minutes on days 1, 3, and 5 followed by rest. Treatment repeats every 4 weeks for up to a total of 10 courses in the absence of dose limiting toxicity, complete response or disease progression. Patients are followed at 1, 3, 6,12,15,18, 21, 24 months following the start of the last treatment cycle.
Cohorts of 3-6 patients each will receive escalating doses of recombinant CAT-8015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, between16 to 25 new patients will be added to the MTD cohort depending on how well the CAT-8015 is tolerated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
DISEASE CHARACTERISTICS:
At least one of the following indications for treatment:
PATIENT CHARACTERISTICS:
Performance status • ECOG 0-2
Life expectancy
• Life expectancy of greater than 6 months, as assessed by the principal investigator
Other
EXCLUSION CRITERIA:
Hepatic function: serum transaminases (either ALT or AST) or bilirubin:
• ≥ Grade 2, unless bilirubin is due to Gilbert’s disease
Renal function: serum creatinine clearance ≤60mL/min as estimated by Cockroft-Gault formula
Hematologic function:
Pulmonary function:
• Patients with < 50% of predicted forced expiratory volume (FEV1) or <50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Note: Patients with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed following bronchodilator therapy.
Recent prior therapy:
United States, California | |
Stanford University School of Medicine | Not yet recruiting |
Stanford, California, United States, 94305 | |
Contact: Sylvia Quesada, RN 650-725-4041 | |
Principal Investigator: Steven E Coutre, MD | |
United States, Illinois | |
Cancer Center of Northwestern University | Not yet recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Simbi Acharya 312-695-1383 | |
Principal Investigator: Martin Tallman, MD | |
United States, Maryland | |
Warren Grant Megnuson Clinical Center – NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: NCI Clinical Trials Referral 888-624-1937 | |
Principal Investigator: Robert J Kreitman, MD | |
Poland | |
Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz) | Not yet recruiting |
Lodz, Poland | |
Contact: Krzysztof Jamroziak, MD (48) 42 689-5191 | |
Principal Investigator: Tadeusz Robak, Professor | |
United Kingdom | |
Royal Marsden Hospital and Institute of Cancer Research | Not yet recruiting |
Surrey, United Kingdom | |
Contact: Claire Dearden, MD (44) 20 7352 8171 | |
Principal Investigator: Claire Dearden, MD |
Study ID Numbers: | CAT-8015-1001 |
Study First Received: | April 16, 2007 |
Last Updated: | April 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00462189 |
Health Authority: | United States: Food and Drug Administration |
CAT-8015 HA22 HCL Relapse |
Refractory immunotherapy immunotoxin |
Lymphatic Diseases Leukemia Leukemia, Hairy Cell Immunoproliferative Disorders |
Lymphoproliferative Disorders Hairy cell leukemia Immunotoxins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |