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Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin, HIV Infections

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Trial Information

Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome


Patients receive infusions of MGBG on days 1 and 8 and every 2 weeks thereafter. It is
suggested that a lumbar puncture be performed to evaluate for leptomeningeal disease.

Inclusion Criteria


Inclusion Criteria

Patients must have:

- HIV positivity by ELISA confirmed by Western blot.

- AIDS-related NHL that is refractory or relapsed.

- Life expectancy of at least 12 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

- Concomitant malignancy OTHER THAN curatively treated carcinoma in situ of the cervix;
basal or squamous cell carcinoma of the skin; or non-active, non-visceral Kaposi's
sarcoma not requiring active chemotherapy.

- Active uncontrolled bacterial infection, viral infection (other than herpes simplex),
or fungal infection (other than oropharyngeal candidiasis) that requires treatment
within 2 weeks of study entry.

- Significant cardiovascular disease.

Concurrent Medication:

Excluded:

- Hormonal therapy (except medications given for muscle wasting, such as testosterone
or Megace).

- Other chemotherapy.

- Investigational anti-cancer drugs.

Concurrent Treatment:

Excluded:

- Concomitant radiation to sites other than CNS.

Patients with the following prior conditions are excluded:

Prior malignancy OTHER THAN curatively treated carcinoma in situ of the cervix; basal or
squamous cell carcinoma of the skin; or non-active, non-visceral Kaposi's sarcoma not
requiring active chemotherapy.

Recommended:

- Prophylaxis for PCP and oral candidiasis.

Required in patients with leptomeningeal disease:

- Intrathecal methotrexate or cytarabine (Ara-C).

- Leucovorin.

Required in patients with leptomeningeal disease:

Cranial radiation to a helmet field.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

241A

NCT ID:

NCT00002348

Start Date:

Completion Date:

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • Lymphoma, Non-Hodgkin
  • Acquired Immunodeficiency Syndrome
  • Lymphoma, AIDS-Related
  • Mitoguazone
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

ILEX Oncology IncSan Antonio, Texas  782453217