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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Recurrent Adult Hodgkin Lymphoma

Recurrent Mantle Cell Lymphoma

Anaplastic Large Cell Lymphoma

Treatments

Drug: tanespimycin

Study type

Interventional

Funder types

NIH

Identifiers

NCT00117988

P30CA016672 (U.S. NIH Grant/Contract)

NCI-2009-00101 (Registry Identifier)

R21CA117070 (U.S. NIH Grant/Contract)

6936 (Other Identifier)

2004-0792 (Other Identifier)

CDR0000433593

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVE:

I. Determine the complete and partial response rates and time to treatment failure in patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or classical Hodgkin's lymphoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).

SECONDARY OBJECTIVES:

I. Determine the safety of this drug in these patients. II. Determine the biologic effect of this drug on selected molecular targets in primary lymphoma cells from these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type (anaplastic large cell lymphoma vs mantle cell lymphoma vs Hodgkin's lymphoma).

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response.

After completion of study treatment, patients are followed every 3 months until disease progression.

Enrollment

22 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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 </= 40% by MUGA
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.