NCT00004241

Brief Summary

Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with advanced epithelial cancer, malignant lymphoma, or sarcoma

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

6.6 years

First QC Date

January 28, 2000

Last Update Submit

February 6, 2013

Conditions

AIDS-related Peripheral/Systemic LymphomaAIDS-related Primary CNS LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaChondrosarcomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueIntraocular LymphomaMetastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorMetastatic OsteosarcomaNodal Marginal Zone B-cell LymphomaOvarian SarcomaPrimary Central Nervous System Non-Hodgkin LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult Soft Tissue SarcomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent OsteosarcomaRecurrent Small Lymphocytic LymphomaRecurrent Uterine SarcomaSmall Intestine LymphomaSplenic Marginal Zone LymphomaStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Hodgkin LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Adult Soft Tissue SarcomaStage IV Adult T-cell Leukemia/LymphomaStage IV Cutaneous T-cell Non-Hodgkin LymphomaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Mycosis Fungoides/Sezary SyndromeStage IV Small Lymphocytic LymphomaStage IV Uterine SarcomaUnspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • MTD defined as the dose level preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT) assessed using Common Toxicity Criteria version 2.0

    4 weeks

Study Arms (2)

Schedule B (tanespimycin)

EXPERIMENTAL

Patients receive 17-AAG IV over 1-2 hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: tanespimycinOther: pharmacological study

Schedule C (tanespimycin)

EXPERIMENTAL

Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Drug: tanespimycinOther: pharmacological study

Interventions

tanespimycinDRUG

Given IV

Also known as: 17-AAG
Schedule B (tanespimycin)Schedule C (tanespimycin)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Schedule B (tanespimycin)Schedule C (tanespimycin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed advanced epithelial cancer, malignant lymphoma, or sarcoma for which no standard curative therapy exists
  • Brain metastases allowed after definitive radiotherapy
  • Performance status - ECOG 0-2
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 2 times normal
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for at least 1 week before, during, and for at least 2 weeks after study completion
  • No active infection
  • No other serious concurrent condition
  • No prior allergic reaction to egg products
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Lymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyChondrosarcomaIntraocular LymphomaNeuroectodermal Tumors, Primitive, PeripheralOsteosarcomaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaSarcomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathyNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueEye NeoplasmsNeoplasms by SiteNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms, Bone TissueLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ramesh Ramanathan

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2000

First Posted

January 27, 2003

Study Start

October 1, 1999

Primary Completion

May 1, 2006

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

US(1)