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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


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.

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Barbara Gallimore, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Inex Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000068259

NCT ID:

NCT00006383

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • anaplastic large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Vermont Cancer CenterBurlington, Vermont  05401-3498
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of Texas Health Center at TylerTyler, Texas  75708
University of Illinois at ChicagoChicago, Illinois  60612
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526