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Brain and Central Nervous System TumorsPhase 1NCT00019058

Radiation Therapy in Treating Patients With Glioblastoma

A Phase 1 study testing chemotherapy, hydroxyurea and pentoxifylline in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) 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: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as pentoxifylline and hydroxyurea may make tumor cells more sensitive to radiation therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
chemotherapy, hydroxyurea and pentoxifylline
Type of treatment
Surgery or procedure
How many people
34 participants
Where
1 siteUnited States
Study dates
Apr 1995to not given
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 grade IV astrocytoma or glioblastoma multiforme confined to 1 or both hemispheres of the brain Confirmation of histology by NIH neuropathology review required MRI or CT completed within 3 weeks of initial evaluation No clinically apparent leptomeningeal metastases No uncontrolled seizures despite standard anticonvulsant therapy No history of epilepsy diagnosed a year or more before glioblastoma

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 80-100% OR ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,500/mm3 Absolute granulocyte count at least 900/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL No hematologic disease requiring treatment Hepatic: Liver function tests no greater than 2.5 times upper limit of normal No hepatic disease requiring treatment Renal: Creatinine no greater than 1.3 mg/dL OR Creatinine clearance at least 95 mL/min No renal disease requiring treatment Cardiovascular: No history of hospitalization or medication for: Cardiovascular disease with LVEF 45% or less Myocardial infarction Arrhythmia Coronary artery disease Angina Congestive heart failure Stroke No thromboembolic disease requiring treatment Pulmonary: No history of hospitalization or medication for chronic obstructive pulmonary disease or asthma Other: No peptic ulcer disease or inflammatory bowel disease within the past 2 years No documented history of intolerance to methylxanthines (e.g., allergic or serious adverse reactions) No history of psychiatric or medical illness that would preclude therapy No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No contraindication to serial CT or MRI (e.g., logistical problems, noncompliance, contrast allergies) Not pregnant or nursing Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Prior biopsy or subtotal or near-total resection allowed At least 7-10 days but no more than 3 months since prior surgery and/or biopsy Other: No recent methylxanthine-containing medications No concurrent anticoagulants or methylxanthines (e.g., aspirin, nonsteroidal antiinflammatory drugs, warfarin, heparin, theophylline, aminophylline, theobromine) for preexisting medical conditions

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Radiation Oncology Branch

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A PHASE I STUDY OF COMBINED RADIATION RESPONSE MODIFIERS EMPLOYING HYDROXYUREA AND PENTOXIFYLLINE FOR TREATMENT OF GLIOBLASTOMA

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as pentoxifylline and hydroxyurea may make tumor cells more sensitive to radiation therapy.

PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus pentoxifylline and hydroxyurea in treating patients who have high-grade astrocytoma or glioblastoma.

Read the detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of pentoxifylline administered with hydroxyurea during a course of cranial radiotherapy in patients with glioblastoma multiforme. II. Determine the toxicity of this regimen in these patients. III. Measure PTX levels in plasma and CSF in order to assess whether therapeutic drug exposures (e.g., 0.4-2.0 mM/24 hours) can be achieved with an acceptable level of toxicity. IV. Assess the local control of glioblastoma in patients treated with this regimen. V. Determine the response of surrounding normal brain in patients treated with this regimen. VI. Determine the survival of patients treated with this regimen.

OUTLINE: This is a dose escalation study of pentoxifylline (PTX). Patients receive hydroxyurea (HU) and PTX IV continuously 5 days a week concurrently with cranial radiotherapy twice daily, 5 days a week, for 4 weeks in the absence of disease progression or unacceptable toxicity. The first cohort of 3 patients is treated with radiotherapy and HU alone. Subsequent cohorts of 3-6 patients receive HU and radiotherapy plus escalating doses of PTX until the maximum tolerated dose of PTX is determined or serum or CSF drug concentrations reach 0.4-2.0 mM in 6 consecutive patients with acceptable toxicity. The MTD is defined as the dose immediately preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 1 week, at 1 and 3 months, every 3 months for 2 years, and then every 4 months for 5 years.

PROJECTED ACCRUAL: A maximum of 24-34 patients will be accrued for this study.

Being tested
chemotherapy, hydroxyurea, pentoxifylline, radiation therapy
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

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

  • chemotherapyDrug

  • hydroxyureaDrug

  • pentoxifyllineDrug

  • radiation therapyRadiation

Timeline

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

  1. First posted5 Apr 2004 (estimated)
  2. Study startApr 1995

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
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019058
Sponsor's protocol ID
CDR0000064077
Other IDs
NCI-95-C-0069, NCI-95-C-0069A, NCI-95-C-0069D
Status last verified
Dec 2001
First submitted
11 Jul 2001
Last updated
29 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing chemotherapy, hydroxyurea and pentoxifylline in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI) 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 29 Apr 2015. 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 29 Apr 2015.

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