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LymphomaPhase 1NCT00088868

17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in Treating Patients With an Advanced Solid Tumor or Lymphoma

A Phase 1 study testing alvespimycin hydrochloride in people with Lymphoma and Small Intestine Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
alvespimycin hydrochloride
How many people
40 participants
Where
1 siteUnited States
Study dates
Jun 2004to Dec 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant solid tumor OR lymphoma
  • Metastatic or unresectable disease
  • Standard curative or palliative measures are not available OR are associated with minimal survival benefit
  • No known brain metastases
  • Treated brain metastases allowed provided they have been stable ≥ 6 months without steroids or anti-seizure medications

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 3,000/mm^3
  • Hemoglobin > 8 g/dL

Hepatic

  • AST and ALT ≤ 2 times upper limit of normal
  • Bilirubin ≤ 1.5 times normal
  • PT and PTT ≤ 1.5 times normal (unless due to the presence of lupus anticoagulant or stable anticoagulation)

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No orthostatic hypotension > grade 2 (requiring more than brief fluid replacement or other therapy OR with physiological consequences)
  • No New York Heart Association class III or IV heart failure
  • LVEF ≥ 40% by MUGA
  • QTc ≤ 450 msec (470 msec for women)
  • No congenital long QT syndrome
  • No myocardial infarction within the past year
  • No active ischemic heart disease within the past year
  • No history of uncontrolled dysrhythmias
  • No history of serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia > 3 premature ventricular contractions in a row)
  • Not requiring antiarrhythmic drugs
  • No poorly controlled angina
  • No left bundle branch block

Pulmonary

  • No uncontrolled symptomatic pulmonary disease, including any of the following:
  • Dyspnea off or on exertion
  • Paroxysmal nocturnal dyspnea
  • Severe chronic obstructive/restrictive pulmonary disease requiring daily chronic medications and oxygen
  • Must not meet the Medicare criteria for home oxygen
  • No sufficiently compromised pulmonary status as measured by baseline pulmonary function tests and DLCO

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study participation
  • No known HIV positivity
  • No hyponatremia indicated by sodium < 130 mmol/L
  • No known immunodeficiency syndromes
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin (geldanamycin or 17-AAG)
  • No concurrent uncontrolled illness
  • No active or ongoing uncontrolled infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior biologic therapy and recovered
  • No concurrent prophylactic growth factors

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin, 8 weeks for UCN-01) and recovered

Endocrine therapy

  • See Disease Characteristics
  • Concurrent hormonal therapy for prostate cancer allowed provided patient has metastatic disease that has progressed despite prior hormonal therapy

Radiotherapy

  • More than 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy that included the heart in the field (e.g., mantle radiotherapy)

Surgery

  • At least 4 weeks since prior major surgery

Other

  • At least 2 weeks since prior participation in a phase 0 study
  • Concurrent bisphosphonates for any cancer allowed
  • Concurrent preventative doses of aspirin or non-steroidal anti-inflammatory drugs allowed
  • No concurrent drugs that may prolong QTc interval
  • No concurrent full anticoagulation on a regular basis
  • No concurrent prophylactic antiemetics
  • No other concurrent investigational agents or therapies
  • No other concurrent anticancer agents or therapies

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: A Phase I Study Of 17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17DMAG) With Evaluation Of Hsp90 Client Proteins In Subjects With Solid Tumors And Lymphomas

RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with an advanced solid tumor or lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with an advanced malignant solid tumor or lymphoma.
  • Determine the dose-limiting toxic effects and toxicity profile of this drug in these patients.

Secondary

  • Compare the effects of this drug on heat shock protein 90 (Hsp90) client proteins when assayed in peripheral blood mononuclear cells (PBMC) vs tumor tissue from patients treated with this drug.
  • Correlate disturbances in key signaling pathways with administration of this drug in these patients.
  • Determine the dose that alters key proteins in the majority of patients treated with this drug.
  • Correlate serum proteomic patterns with target interactions or DMAG clinical effects in patients treated with this drug.
  • Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a single-center, dose-escalation study.

Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-2 hour on days 1 and 4 or days 2 and 5 weekly for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of 17-DMAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at the MTD.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study within 2 years.

Being tested
alvespimycin hydrochloride
Keywords
unspecified adult solid tumor, protocol specific, anaplastic large cell lymphoma, intraocular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large-Cell, Anaplastic, Intraocular Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell, Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alvespimycin hydrochlorideDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionMar 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00088868
Sponsor's protocol ID
040218
Other IDs
04-C-0218, NCI-6544, CDR0000377488
Status last verified
Mar 2012
First submitted
4 Aug 2004
Last updated
15 Mar 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing alvespimycin hydrochloride in people with Lymphoma and Small Intestine Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2012.

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