Phase 2
N=22
17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma · Recurrent Adult Hodgkin Lymphoma · Recurrent Mantle Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00117988 ↗Enrolled (actual)
22
Serious AEs
13.6%
Results posted
May 2011
Primary outcome: Primary: Number of Patients With Response — 0; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- tanespimycin (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Response |
0; 2 | — |
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 = = 75,000/mm3
- AST and ALT = /= 450 msec for men
- QTc >/= 470 msec for women
- LVEF = grade 2
- No sufficiently compromised pulmonary status (i.e., DLCO = = 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.
Data sourced from ClinicalTrials.gov (NCT00117988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.