Lymphoma Clinical Trial
Official title:
Phase II Evaluation of Gallium Nitrate (NSC 15200) in Non-Hodgkin's Lymphoma in Patients With Acquired Immunodeficiency Syndrome
Verified date | October 2015 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Chemotherapy uses different ways to stop cancer cells from dividing so they stop
growing or die.
PURPOSE: Phase II trial to study the effectiveness of gallium nitrate in treating patients
with AIDS-related non-Hodgkin's lymphoma.
Status | Completed |
Enrollment | 35 |
Est. completion date | |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
DISEASE CHARACTERISTICS: Histologically proven stage I-IV AIDS-related non-Hodgkin's
lymphoma Intermediate- or high-grade disease HIV infection documented by ELISA and
confirmed by Western blot Must have received at least 1 potentially curative chemotherapy
regimen for lymphoma Must be past the hematologic nadir resulting from prior chemotherapy
(generally 2 weeks from onset of prior therapy regardless of filgrastim (G-CSF) use)
Waiting period waived at the discretion of the principal investigator if patient
well-being would be compromised At least 1 site of bidimensionally measurable or evaluable
disease (e.g., bone marrow involvement only) History of leptomeningeal disease associated
with systemic lymphoma allowed No primary CNS non-Hodgkin's lymphoma A new classification
scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of
"indolent" or "aggressive" lymphoma will replace the former terminology of "low",
"intermediate", or "high" grade lymphoma. However, this protocol uses the former
terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: Granulocyte count at least 750/mm3* Platelet count at least 50,000/mm3* Hemoglobin at least 7.5 g/dL* * Unless bone marrow infiltrated by lymphoma Hepatic: Bilirubin less than 1.25 times upper limit of normal AST no greater than 3.0 times normal Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months No history of congestive heart failure No angina No serious arrhythmia requiring treatment Other: No other prior or concurrent malignancy except: Inactive, nonvisceral Kaposi's sarcoma not requiring chemotherapy Curatively treated basal cell or squamous cell skin cancer Curatively treated carcinoma in situ of the cervix No severe, acute opportunistic infection No acute or intermittent infection (other than oropharyngeal candidiasis) requiring treatment within 2 weeks before study entry Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior biologic therapy allowed Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior radiotherapy allowed No concurrent radiotherapy Surgery: Not specified Other: No concurrent investigational anticancer or anti-infective therapy No concurrent aminoglycosides, amphotericin B, or foscarnet Concurrent required supportive care allowed, including: Non-investigational antiretroviral and antiviral medications Medications for Mycobacterium avium DISEASE CHARACTERISTICS: Histologically proven stage I-IV AIDS-related non-Hodgkin's lymphoma Intermediate- or high-grade disease HIV infection documented by ELISA and confirmed by Western blot Must have received at least 1 potentially curative chemotherapy regimen for lymphoma Must be past the hematologic nadir resulting from prior chemotherapy (generally 2 weeks from onset of prior therapy regardless of filgrastim (G-CSF) use) Waiting period waived at the discretion of the principal investigator if patient well-being would be compromised At least 1 site of bidimensionally measurable or evaluable disease (e.g., bone marrow involvement only) History of leptomeningeal disease associated with systemic lymphoma allowed No primary CNS non-Hodgkin's lymphoma A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: Granulocyte count at least 750/mm3* Platelet count at least 50,000/mm3* Hemoglobin at least 7.5 g/dL* * Unless bone marrow infiltrated by lymphoma Hepatic: Bilirubin less than 1.25 times upper limit of normal AST no greater than 3.0 times normal Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months No history of congestive heart failure No angina No serious arrhythmia requiring treatment Other: No other prior or concurrent malignancy except: Inactive, nonvisceral Kaposi's sarcoma not requiring chemotherapy Curatively treated basal cell or squamous cell skin cancer Curatively treated carcinoma in situ of the cervix No severe, acute opportunistic infection No acute or intermittent infection (other than oropharyngeal candidiasis) requiring treatment within 2 weeks before study entry Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior biologic therapy allowed Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Prior radiotherapy allowed No concurrent radiotherapy Surgery: Not specified Other: No concurrent investigational anticancer or anti-infective therapy No concurrent aminoglycosides, amphotericin B, or foscarnet Concurrent required supportive care allowed, including: Non-investigational antiretroviral and antiviral medications Medications for Mycobacterium avium intracellulare infection Medications for cytomegalovirus (CMV) infection or CMV infection prophylaxis infection Medications for cytomegalovirus (CMV) infection or CMV infection prophylaxis |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein Comprehensive Cancer Center | Bronx | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | USC/Norris Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | National Cancer Institute (NCI) |
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