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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00003708

Chemotherapy in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing temozolomide in people with Unspecified Adult Solid Tumor, Protocol Specific, run by The University of Texas Health Science Center at San Antonio at 2 sites 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 temozolomide in treating patients who have advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
temozolomide
Type of treatment
Pill or oral medicine
How many people
32 participants
Where
2 sitesUnited States
Study dates
Jul 1998to May 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 or cytologically proven solid malignancy for which no curative therapy exists Glioblastoma eligible if following criteria are met: Stable performance status Stable symptoms At least 4 weeks on stable dose of dexamethasone CNS metastases allowed if no progression or no new edema present Measurable or evaluable disease No acute or chronic leukemia or multiple myeloma No known bone marrow involvement with tumor

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 3 times upper limit of normal (ULN) (5 times ULN if due to liver metastases) Renal: Creatinine no greater than 1.5 mg/dL Other: No malabsorption syndrome due to prior surgery, gastrointestinal disease, or other unknown reason No concurrent nonmalignant systemic disease No active uncontrolled infection No frequent vomiting or medical condition that could interfere with oral medication uptake (e.g., partial bowel obstruction, bowel resection, partial intestinal bypass, external biliary diversion) No prior or concurrent malignancies at other sites except carcinoma in situ of the cervix or adequately treated basal or squamous cell skin cancer HIV negative No AIDS-related illness Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No prior allogeneic, syngeneic, or autologous bone marrow transplantation No prior peripheral blood stem cell transplantation No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior radiotherapy to at least 25% of bone marrow (including pelvic irradiation) and recovered No concurrent radiotherapy Surgery: Prior major gastrointestinal surgery allowed (e.g., Whipple procedure) Other: At least 4 weeks since any prior investigational therapy At least 24 hours since prior alcohol consumption

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • San Antonio Cancer Institute

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase I Study of Cyclic Oral Administration of SCH 52365 for 21 of 28 Days in Patients With Advanced 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 temozolomide in treating patients who have advanced solid tumors.

Read the detailed description

OBJECTIVES: I. Determine the safety, tolerability, maximum tolerated dose, and dose limiting toxicity of temozolomide in patients with advanced solid malignancies. II. Characterize the single- and multiple-dose pharmacokinetics of temozolomide following oral administration in these patients. III. Determine antitumor activity of temozolomide in these patients.

OUTLINE: This is an open label, dose escalation study. Patients receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2 patients experiencing DLT at the next higher dose level.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Being tested
temozolomide
Keywords
unspecified adult solid tumor, protocol specific

What participants receive

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

  • temozolomideDrug

    Also called Temodar, Temodal, Temcad

    Patients receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2 patients experiencing DLT at the next higher dose level.

Timeline

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

  1. First posted4 Aug 2004 (estimated)
  2. Study startJul 1998
  3. Primary completionMay 2000
  4. Study completionMay 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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003708
Sponsor's protocol ID
CDR0000066816
Other IDs
P30CA054174, UTHSC-9785011336, SACI-IDD-98-09, SPRI-C98-247, NCI-V98-1502
Status last verified
Aug 2012
First submitted
1 Nov 1999
Last updated
9 Aug 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing temozolomide in people with Unspecified Adult Solid Tumor, Protocol Specific, run by The University of Texas Health Science Center at San Antonio at 2 sites 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 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 9 Aug 2012.

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