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Recurrent MelanomaPhase 2NCT00072163

Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma

A Phase 2 study testing temozolomide and thalidomide in people with Recurrent Melanoma and Stage IV Melanoma, 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

This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor 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?
temozolomide and thalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Oct 2003to Sep 2006
Phase
Phase 2
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

Who may be able to join

  • Histologically or cytologically confirmed metastatic melanoma
  • Clinical evidence of brain metastases
  • At least 1 unidimensionally measurable brain lesion at least 2.0 cm by conventional techniques OR at least 1.0 cm by spiral CT scan or MRI
  • The following lesions are not considered measurable:
  • Bone lesions
  • Leptomeningeal disease
Show all 55Show fewer
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Lesions situated in a previously irradiated area, unless new growth is documented
  • Performance status - CTC 0-1
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • AST and ALT no greater than 2.5 times upper limit of normal (ULN)
  • Lactic dehydrogenase no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Creatinine no greater than 2 mg/dL
  • No history of active angina
  • No history of significant ventricular arrhythmia
  • No history of deep vein thrombosis
  • No myocardial infarction within the past 6 months
  • No acute abnormality by EKG
  • No uncontrolled arrhythmia
  • No history of pulmonary embolism
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 1 highly-effective and 1 additional method of contraception for 28 days before, during, and for 4 weeks after study participation
  • No known HIV disease
  • Thyroid-stimulating hormone normal
  • Serum anticonvulsant levels normal (for patients on anticonvulsants)
  • No frequent vomiting and/or any other medical condition (e.g., partial bowel obstruction) that would preclude oral medication intake
  • No preexisting neuropathy greater than grade 1
  • No uncontrolled seizures
  • No other concurrent medical condition that would preclude study participation
  • At least 4 weeks since prior cytokines
  • Biologic agents used as adjuvants, vaccines, and cellular therapies do not require a 4-week washout period
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No more than 1 prior chemotherapy regimen
  • No prior chemotherapy for brain metastases
  • No prior continuous daily temozolomide
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy
  • No concurrent hormonal therapy except steroids and hormones administered for non-disease-related conditions (e.g., insulin for diabetes) or for control of intracranial edema from brain metastases
  • See Disease Characteristics
  • Prior whole brain radiotherapy (WBRT) allowed provided patient has progressive disease in a measurable CNS lesion
  • Prior stereotactic radiotherapy allowed provided patient has progressive disease in a measurable CNS lesion
  • At least 4 weeks since prior WBRT
  • At least 3 weeks since prior stereotactic radiosurgery
  • No concurrent radiotherapy
  • At least 3 weeks since prior surgical resection
  • No concurrent warfarin or heparin products or their derivatives
  • No concurrent antiplatelet therapy (e.g., daily aspirin, ibuprofen, or clopidogrel bisulfate)
  • No concurrent bisphosphonates (e.g., zoledronate)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cancer and Leukemia Group B

    Chicago, Illinois, 60606

Other trials in United States

About this study

Official title: A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain

This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells

Read the detailed description

OBJECTIVES: Primary I. Determine the objective response rate in patients with brain metastases secondary to melanoma treated with temozolomide and thalidomide.

Secondary I. Determine the toxic effects of and tolerance to this regimen in these patients.

II. Determine the objective response rate in extracranial metastases of patients treated with this regimen.

III. Determine the time to first disease progression (intra- or extracranial) in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 2 years.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 1.5 years.

Medical subject headings
Melanoma, Brain Neoplasms

What participants receive

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

  • temozolomideDrug

    Also called SCH 52365, Temodal, Temodar, TMZ

    Given orally

  • thalidomideDrug

    Also called Kevadon, Synovir, THAL, Thalomid

    Given orally

Study groups in NCT00072163
Study groupRoleWhat they receive
Treatment (temozolomide, thalidomide)ExperimentalPatients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses of therapy beyond CR.
Receives: Drug: temozolomide; Drug: thalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate (defined as complete or partial)

    90% confidence intervals will be used.

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Time to first progression

    Kaplan-Meier method will be used.

    Measured: Up to 5 years

  2. Overall survival

    Kaplan-Meier method will be used.

    Measured: Up to 5 years

Timeline

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

  1. First posted6 Nov 2003 (estimated)
  2. Study startOct 2003
  3. Primary completionSep 2006

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072163
Sponsor's protocol ID
NCI-2012-02560
Other IDs
CALGB-500102, U10CA031946, CDR0000335518
Status last verified
Jan 2013
First submitted
4 Nov 2003
Last updated
17 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temozolomide and thalidomide in people with Recurrent Melanoma and Stage IV Melanoma, 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?

The sponsor lists 55 inclusion and 0 exclusion criteria. 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 17 Jan 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Response rate (defined as complete or partial) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00072163.

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 17 Jan 2013.

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