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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study of 17-AAG in Patients With Relapsed/Refractory CD30+ Anaplastic Large Cell Lymphoma (ALCL), Relapsed/Refractory Mantle Cell Lymphoma (MCL), and Relapsed/Refractory Classical Hodgkin's Lymphoma (HL)

Conditions
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Anaplastic Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Mantle Cell Lymphoma

Intervention / Treatment
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* Drug: tanespimycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: tanespimycin<br> <br> * Other names: 17-AAG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Response | Number of participants who experience complete response or partial response. Partial Response=>50% decrease in lympho node masses. Complete Response=>-75% decrease in lymph node masses. | Baseline to time to best response; Every 6 weeks |