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Phase II Evaluation of Gallium Nitrate (NSC 15200) in Non-Hodgkin's Lymphoma in Patients With Acquired Immunodeficiency Syndrome


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Phase II Evaluation of Gallium Nitrate (NSC 15200) in Non-Hodgkin's Lymphoma in Patients With Acquired Immunodeficiency Syndrome


OBJECTIVES: I. Determine the response rate and duration of response in patients with
AIDS-related non-Hodgkin's lymphoma treated with gallium nitrate after failure on first-line
chemotherapy regimen. II. Determine the qualitative and quantitative toxic effects of this
regimen in these patients. III. Determine the pharmacokinetic parameters of this regimen in
these patients, and determine if there is a correlation between those parameters and
response.

OUTLINE: Patients receive gallium nitrate IV continuously on days 1-7. Courses repeat every
4 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve
complete remission (CR) receive 2 additional courses past CR. Patients who relapse after
achieving CR may be retreated in the absence of disease progression. Treatment for relapse
after a second CR is at the discretion of the principal investigator. Patients with
leptomeningeal disease at study entry must receive intrathecal (IT) methotrexate with IV
leucovorin calcium or IT cytarabine. Patients who develop leptomeningeal disease while on
study may continue treatment with gallium nitrate but must also receive IT methotrexate and
leucovorin calcium (with or without radiotherapy) or IT cytarabine. Patients are followed
for survival.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 2 years.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lawrence P. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albany Medical College

Authority:

United States: Federal Government

Study ID:

DS 96-26

NCT ID:

NCT00002578

Start Date:

August 1994

Completion Date:

Related Keywords:

  • Lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related diffuse large cell lymphoma
  • AIDS-related immunoblastic large cell lymphoma
  • AIDS-related small noncleaved cell lymphoma
  • AIDS-related diffuse mixed cell lymphoma
  • AIDS-related diffuse small cleaved cell lymphoma
  • AIDS-related lymphoblastic lymphoma
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800