CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Vorinostat +1 moredrug
Likely dose
Vorinostat (SAHA) given orallyAI-extracted
Key inclusion· 6
  • Histologically or cytologically confirmed relapsed/refractory indolent non-Hodgkin's lymphoma (follicular grade I-III, marginal zone, or mantle cell)
  • Measurable disease by CT scan (PET scan desirable but not required)
  • Up to 4 prior chemotherapy regimens allowed; steroids and local radiation do not count as regimens; rituximab alone does not count, but Bexxar or Zevalin do; most recent therapy must have failed to induce complete response or show disease progression
  • If prior stem cell transplant: ≥3 months post-autologous or ≥6 months post-allogeneic, with platelet count >100,000/mcL and WBC >1,000/mcL achieved, no active infections, and no acute GvHD (allogeneic only); chronic GvHD limited to mild skin/oral/ocular without systemic immunosuppression
Key exclusion· 9
  • Chemotherapy within 4 weeks, rituximab within 3 months (unless disease progression evident), or radiotherapy within 2 weeks; steroids may continue until 2 days prior to enrollment
  • Special washout periods: low-dose chlorambucil 2 weeks prior, valproic acid ≥2 weeks prior, nitrosoureas and mitomycin 6 weeks prior
  • Brain metastases excluded unless controlled and no steroid treatment in past 2 months
  • Known allergic reactions to compounds of similar chemical or biologic composition to SAHA

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00253630
NCT00253630Phase 2Completed

A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Indolent Non-Hodgkin's Lymphoma

National Cancer Institute (NCI)·interventional·Posted Nov 15, 2005·Updated Mar 6, 2018

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis and Vorinostat for Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue and 6 related conditions. Completed, enrolled 37 participants across 5 sites.

Detailed Summary

This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory indolent non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 15, 2005
Enrollment StartSep 1, 2005
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 20.6 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Vorinostatdrug

Given PO