17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma
Condition: Anaplastic Large Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma, Mantle-Cell; Lymphoma, Large-Cell, Anaplastic; Recurrence
Intervention: tanespimycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

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.
    

Eligibility 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 </= 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.