17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is studying how well 17-AAG works in treating patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or Hodgkin's lymphoma. Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Negative pregnancy test

• Fertile patients must use effective contraception prior to and during study treatment

• Must have normal organ and marrow function

• Not a candidate for stem cell transplantation

• ECOG 0-2 OR Karnofsky 60-100%

• Bilirubin normal

• Creatinine normal

• Histologically or cytologically confirmed relapsed or refractory mantle cell lymphoma, anaplastic large cell lymphoma (CD30-positive disease), or classical Hodgkin's lymphoma

• Recovered from prior biologic therapy or autologous stem cell transplantation

• Prior antibody therapy within the past 3 months allowed

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• More than 4 weeks since prior radiotherapy (12 weeks for radioimmunotherapy) and recovered

• Recovered from prior investigational drugs

• Recovered from prior surgery

• More than 4 weeks since other prior anticancer therapy

• Concurrent low-molecular weight heparin is allowed

• Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm

• Absolute neutrophil count >= 1,500/mm3

• Received >= 1, but =< 3, prior treatment regimens for lymphoma (salvage therapy followed immediately by stem cell transplantation is considered 1 regimen). Single-agent monoclonal antibody therapy, cytokine therapy, or involved field radiotherapy are not considered prior treatment regimens. All prior treatments and prior antibody therapy within the past 3 months are recorded.

• Platelet count >= 75,000/mm3

• AST and ALT =< 1.5 times upper limit of normal

• Understand and provide signed informed consent.

Exclusion Criteria:

• No cardiac arrhythmia or uncontrolled dysrhythmia

• No history of myocardial infarction within the past year

• No New York Heart Association class III or IV heart failure

• No other significant cardiac disease

• No paroxysmal nocturnal dyspnea

• No oxygen requirement

• No AIDS

• No history cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubcin hydrochloride, mitoxantrone, bleomycin, or carmustine)

• No pulmonary lymphoma

• No known CNS lymphoma

• QTc >/= 450 msec for men

• QTc >/= 470 msec for women

• LVEF
• No symptomatic congestive heart failure

• No unstable angina pectoris

• No symptomatic pulmonary disease requiring medication

• No significant pulmonary disease including chronic obstructive or restrictive pulmonary disease

• No dyspnea on or off exertion

• No history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubcin hydrochloride, mitoxantrone, bleomycin, or carmustine)

• Not pregnant or nursing

• No other uncontrolled illness

• No other active* malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No prior allogeneic stem cell transplantation

• No history of allergic reaction to eggs

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• No prior chest radiation or prior radiation that potentially included the heart in the field (e.g.,mantle).

• No concurrent medications that prolong or may prolong QTc

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent investigational agents

• No other concurrent anticancer therapy

• No prior cardiac symptoms >= grade 2

• No sufficiently compromised pulmonary status (i.e., DLCO =< 80%)

• No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation >= 3 beats in a row)

• No prior pulmonary symptoms >= grade 2

• HIV negative

• No active ischemic heart disease within 12 months.

• No congenital long QT syndrome.

• No left bundle branch block.