17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma
Completed · Phase 2
Conditions studied: Anaplastic Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Mantle Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT00117988
- Run by
- National Cancer Institute (NCI)
- People needed
- 22
- Starts
- 2005-02-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2014-05-30
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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