Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of liposomal vincristine in treating patients who have refractory or relapsed non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: liposomal vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell Non-Hodgkin's Lymphoma That is Refractory or Relapsed After Second-Line Combination Chemotherapy Revised Title Per 03/01 SR Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Aggressive Non-Hodgkin's Lymphoma That is Refractory to or Relapsed After Second-Line Combination Chemotherapy |
| Study Start Date: | June 2000 |
OBJECTIVES:
- Determine the complete and partial tumor responses in patients with aggressive non-Hodgkin's lymphoma that is refractory to or relapsed after second-line combination chemotherapy treated with vincristine sulfate liposomes injection.
- Determine the toxicity of this treatment regimen in these patients.
- Determine the duration of response, time to progression, and survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive vincristine sulfate liposomes IV over 1 hour. Treatment repeats every 2 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma including:
- Peripheral T-cell lymphoma not otherwise specified
- Anaplastic large null-/T-cell lymphoma
Diffuse large B-cell lymphoma including:
- Primary mediastinal large B-cell lymphoma with sclerosis
- Intravascular large B-cell lymphoma
- Immunoblastic B-cell lymphoma
- T-cell-rich B-cell lymphoma
- Anaplastic large B-cell lymphoma
- At least one bidimensionally measurable lesion with clearly defined margins at least 2 cm in the largest dimension by physical examination or CT scan
- No prior or active CNS lymphoma or AIDS-related lymphoma
Must have received 2 or more prior chemotherapy courses from time of diagnosis of aggressive lymphoma or from time of biopsy-proven transformation from indolent to aggressive
- Prior first and second-line therapy must have been combination chemotherapy
- Prior first-line chemotherapy regimen must have contained anthracycline
- Must have had at least a minor response to first-line therapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-3
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 500/mm^3 (unless due to lymphoma bone marrow involvement)
- Platelet count at least 50,000/mm^3 (unless due to lymphoma bone marrow involvement)
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- ALT no greater than 4 times ULN
- Alkaline phosphatase no greater than 4 times ULN
Renal:
- Not specified
Neurologic:
- No prior neurological disorders unrelated to chemotherapy (including familial neurological diseases or acquired demyelinating disorders)
- No neuromuscular impairment (neuromotor, neurosensory, or neurocerebellar)
- No prior grade 3 or 4 sensory or motor neuropathy related to chemotherapy
Other:
- No uncontrolled severe medical illness or infection
- HIV negative
- No other malignancies within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Radiotherapy
- No prior allogeneic bone marrow or peripheral blood stem cell transplantation
- At least 4 weeks since prior immunotherapy
- No concurrent biological agents
Chemotherapy:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- At least 4 weeks since prior corticosteroids at a dose greater than 10 mg/day of prednisone or equivalent
Radiotherapy:
- Prior involved-field radiotherapy allowed if irradiated area is not the only source of measurable disease
- Prior total body radiotherapy with high-dose therapy and autologous stem cell transplantation allowed
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy to any disease site
Surgery:
- At least 4 weeks since prior major surgery except for diagnosis of lymphoma
- No concurrent surgical removal of any indicator lesion
Other:
- At least 4 weeks since prior alternative or investigational anticancer treatment
- No other concurrent systemic anticancer therapy
- No other concurrent investigational drug
- No concurrent phenytoin
- No concurrent hepatic drug metabolism inhibitors or inducers (cytochrome P450 isoenzymes in the CYP 3A subfamily)
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| United States, Illinois | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| University of Texas Health Center at Tyler | |
| Tyler, Texas, United States, 75708 | |
| United States, Vermont | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05401-3498 | |
| Canada, Alberta | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Study Chair: | Barbara Gallimore, PhD | Inex Pharmaceuticals |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00006383 History of Changes |
| Other Study ID Numbers: | CDR0000068259, INEX-CA99002, UCLA-0002028 |
| Study First Received: | October 4, 2000 |
| Last Updated: | January 20, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult T-cell leukemia/lymphoma anaplastic large cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Vincristine Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013