Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma

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

Sponsoren

Hauptsponsor: Inex Pharmaceuticals

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum June 2000
Fertigstellungstermin August 2009
Phase Phase 2
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: liposomal vincristine sulfate

Teilnahmeberechtigung

Kriterien:

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)

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Barbara Gallimore, PhD Study Chair Inex Pharmaceuticals
Ort
Einrichtung:
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California, 90033-0804, United States
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California, 90095-1781, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois, 60611-3013, United States
University of Illinois at Chicago | Chicago, Illinois, 60612, United States
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois, 62526, United States
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio, 44195, United States
University of Texas Health Center at Tyler | Tyler, Texas, 75708, United States
Vermont Cancer Center | Burlington, Vermont, 05401-3498, United States
Tom Baker Cancer Center - Calgary | Calgary, Alberta, T2N 4N2, Canada
Standort Länder

Canada

United States

Überprüfungsdatum

December 2002

Schlüsselwörter
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Studiendesign Info

Hauptzweck: Treatment

Quelle: ClinicalTrials.gov