Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia
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Purpose
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with cyclosporine works in treating older patients with relapsed acute myeloid leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: cyclosporine Drug: gemtuzumab ozogamicin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60 |
- Efficacy in terms of complete remission rate [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Designated as safety issue: No ]
- Correlate clinical response to laboratory studies of drug susceptibility [ Designated as safety issue: No ]
| Study Start Date: | May 2004 |
| Study Completion Date: | March 2006 |
OBJECTIVES:
Primary
- Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the complete remission rate, in older patients with relapsed acute myeloid leukemia.
- Determine the toxicity and pharmacokinetics of this regimen in these patients.
Secondary
- Correlate clinical response with laboratory studies of drug susceptibility in patients treated with this regimen.
OUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17. Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate
- More than 20% blasts by morphologic criteria
- Relapsed disease ≥ 3 months after prior complete remission
- Blasts CD33-positive by flow cytometry
- No primary hematologic disorder that preceded initial presentation with AML
- No documented secondary AML related to prior chemotherapy or toxin exposure
- No acute promyelocytic leukemia (FAB M3)
- Not a candidate for transplant therapy
- No active CNS leukemia
PATIENT CHARACTERISTICS:
Age
- 60 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- WBC ≤ 30,000/mm^3 (hydroxyurea allowed)
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 mg/dL
Other
- HIV negative
- No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not planning hematopoietic stem cell transplantation immediately after study therapy
Chemotherapy
- See Disease Characteristics
- See Hematopoietic
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 1 month since prior investigational agents
- No other concurrent anticancer therapy
No administration of any of the following for 24 hours after cyclosporine administration:
- Diltiazem
- Verapamil
- Erythromycin
- Clarithromycin
- Metoclopramide
- Phenytoin
- Rifampin
- Phenobarbital
- Aminoglycosides
- Amphotericin B
- Vancomycin
- Cimetidine
- Ranitidine
- Trimethoprim/sulfamethoxazole
- Ketoconazole
- Fluconazole
- Itraconazole
- Voriconazole
- Carbamazepine
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Principal Investigator: | Stephen H. Petersdorf, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00089050 History of Changes |
| Other Study ID Numbers: | 1820.00, FHCRC-1820.00, CDR0000378021 |
| Study First Received: | August 4, 2004 |
| Last Updated: | November 28, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
recurrent adult acute myeloid leukemia adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult erythroleukemia (M6a) |
adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) adult acute basophilic leukemia adult acute eosinophilic leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cyclosporins Cyclosporine Gemtuzumab Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013