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Head and Neck CancerPhase 1NCT00003430

L-778,123 in Treating Patients With Recurrent or Refractory Solid Tumors

A Phase 1 study testing L-778,123 in people with Head and Neck Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Memorial Sloan Kettering Cancer Center 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 use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of L-778,123 in treating patients with recurrent or refractory solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
L-778,123
How many people
40 participants
Where
1 siteUnited States
Study dates
Apr 1998to Apr 2000
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 proven recurrent or refractory solid tumors including, but not limited to: Pancreatic cancer Bladder cancer Colon cancer Head and neck cancer Lung cancer Measurable disease or a measurable tumor marker (not based solely on cytopathological data) No primary or active metastatic CNS disease (assessed by edema or 2 radiologic imaging techniques at least 4 weeks apart)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 PT or PTT no greater than 1.2 times upper limit of normal (ULN) Hepatic: Bilirubin no greater than 1.5 time ULN ALT or AST no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No grade 3 cardiac dysrhythmias No atrial fibrillation No prior myocardial infarction No history of unstable angina No history of congestive heart failure LVEF greater than 50% in patients with prior cumulative anthracycline dose less than 450 mg/m2 of doxorubicin Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-barrier contraception for at least 2 weeks before, throughout, and at least 2 weeks after the study Permanent central venous catheter in place No history of illicit drug or alcohol abuse within the past 5 years No emotional or psychiatric disorders No known significant drug allergies or serious adverse experiences with marketed or investigational drugs No allergy to latex Normal serum electrolytes No other serious medical disorders No active infections No history of significant retinal disorder or disease No history of seizure disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunologic therapy No concurrent immunologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy At least 6 weeks since prior mitomycin or nitrosoureas No prior high dose chemotherapy with stem cell rescue No other concurrent chemotherapy No prior anthracycline dose exceeding the equivalent of greater than 45O mg/m2 of doxorubicin Endocrine therapy: At least 4 weeks since prior endocrine therapy (including steroids) No concurrent endocrine therapy Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiation to greater than 25% of total bone marrow No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery No concurrent surgery Other: At least 30 days since prior investigational agents No concurrent medications with dysrhythmic potential including, but not limited to: terfenadine, astemizole, cisapride, diphenhydramine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, tricyclic antidepressants, haloperidol, risperidone, and indapamine No concurrent rifampin, phenobarbital, phenytoin, or other inducers of CYP3A No concurrent triazolam, alprazolam, midazolam, or other CYP3A metabolized benzodiazepines No concurrent HMG-CoA reductase inhibitors (except fluvastatin) No concurrent anticoagulant therapy (low dose warfarin therapy to maintain catheter patency allowed)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: A Pharmacokinetic Study Evaluating the Safety, Tolerability and Maximally Tolerated Dose of 7-Day Continuous Infusions of L-778,123 in Patients With Recurrent of Refractory Solid Malignancies

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of L-778,123 in treating patients with recurrent or refractory solid tumors.

Read the detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of L-778,123 in patients with recurrent or refractory solid tumors. II. Evaluate the safety and tolerability of L-778,123 including qualitative, quantitative, and dose limiting toxicity in these patients. III. Assess the pharmacokinetic profile of this regimen in these patients. IV. Evaluate the radiologic or tumor marker responses to treatment in these patients. V. Evaluate the relationship between ras mutations and response to treatment in these patients. VI. Determine the relationship between plasma drug levels and farnesylation assay results.

OUTLINE: This is a dose escalation study. Patients receive continuous infusions of L-778,123 over 7 days every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxic effects. All patients are observed for at least 1 week after the 7 day infusion of L-778,123 prior to subsequent dose escalation. Cohorts of 3-6 patients receive escalating doses of L-778,123 until the maximum tolerated dose (MTD) is reached. MTD is defined as the dose at which no more than 2 of 6 patients experiences dose limiting toxicities. Patients are followed until death.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Being tested
L-778,123
Keywords
recurrent nasopharyngeal cancer, unspecified adult solid tumor, protocol specific, recurrent lip and oral cavity cancer, recurrent hypopharyngeal cancer, recurrent laryngeal cancer, recurrent paranasal sinus and nasal cavity cancer, recurrent oropharyngeal cancer
Medical subject headings
Head and Neck Neoplasms, Nasopharyngeal Neoplasms, Mouth Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Oropharyngeal Neoplasms

What participants receive

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

  • L-778,123Drug

Timeline

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

  1. First posted13 Sep 2004 (estimated)
  2. Study startApr 1998
  3. Primary completionApr 2000
  4. Study completionApr 2000

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
NCT00003430
Sponsor's protocol ID
98-033
Other IDs
CDR0000066456, MERCK-MSKCC-98033, NCI-G98-1453
Status last verified
Jun 2013
First submitted
1 Nov 1999
Last updated
25 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing L-778,123 in people with Head and Neck Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Memorial Sloan Kettering Cancer Center 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 25 Jun 2013. 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 25 Jun 2013.

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