Status:
COMPLETED
17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Anaplastic Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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 chemot...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00117988
Start Date
February 1 2005
End Date
April 1 2010
Last Update
May 30 2014
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030