17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma

NCT00117988 | Completed Phase 2 Results

• 6 other identifiers: NCI-2009-00101CDR00004335932004-07926936P30CA016672R21CA117070
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anaplastic Large Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Response

  Number of participants who experience complete response or partial response. Partial Response=\>50% decrease in lympho node masses. Complete Response=\>-75% decrease in lymph node masses.

  Baseline to time to best response; Every 6 weeks

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response. After completion of study treatment, patients are followed every 3 months until disease progression.

Drug: tanespimycin

Interventions

tanespimycin DRUG

Also known as: 17-AAG

Arm I

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic; Hodgkin Disease; Lymphoma, Mantle-Cell

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Anas Younes, MD / Professor
• Organization: UT MD Anderson Cancer Center

etubbs@mdanderson.org

Study Officials

• Anas Younes

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 11, 2005
• Study Start: February 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 30, 2014
• Results First Posted: May 30, 2011

Record last verified: 2013-02

Locations

US (1)