AzTrials
AzTrials

Intraocular MelanomaPhase 1/2NCT00005815

Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma

A Phase 1/2 study testing temozolomide and thalidomide in people with Intraocular Melanoma and Melanoma (Skin), 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
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of melanoma by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intraocular Melanoma, Melanoma (Skin)
What is being tested?
temozolomide and thalidomide
How many people
Not given
Where
1 siteUnited States
Study dates
Dec 1999to Aug 2004
Phase
Phase 1/2
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic malignant melanoma that is considered unresectable
  • Stage III or IV ocular, mucosal, or cutaneous melanoma
  • Measurable disease
  • No CNS disease (phase I only)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No history of active angina
  • No myocardial infarction within past 6 months
  • No history of significant ventricular arrhythmia requiring medication with antiarrhythmics

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 4 weeks before and after study
  • No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
  • No preexisting neurotoxicity grade 2 or greater
  • No serious concurrent infections treated with antibiotics
  • No nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study
  • No psychiatric disorders that would preclude study compliance
  • No other medical condition or reason that would preclude study
  • No other malignancy within the past 2 years except:
  • Nonmelanoma skin cancer
  • Carcinoma in situ of the cervix
  • History of T1a or b prostate cancer detected incidentally at TURP and comprising less than 5% of resected tissue with PSA normal since TURP
  • No AIDS related illness
  • HIV negative

PRIOR CONCURRENT THERAPY:

  • Recovered from prior therapy

Biologic therapy:

  • At least 4 weeks since prior biologic therapy
  • At least 4 weeks since prior immunotherapy
  • No concurrent immunotherapy

Chemotherapy:

  • No prior systemic chemotherapy for metastatic melanoma
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery
  • At least 3 weeks since prior radiotherapy to the brain if brain metastases from melanoma
  • Prior radiotherapy to only indicator lesion allowed provided recent evidence of disease progression at that site
  • No concurrent radiotherapy

Surgery:

  • At least 2 weeks since prior surgery requiring general anesthesia

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 Phase I/II Study of Temozolamide and Thalidomide in the Treatment of Advanced Melanoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of melanoma by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness temozolomide plus thalidomide in treating patients who have stage III or stage IV melanoma that cannot be removed during surgery.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of temozolomide using an extended continuous schedule in combination with thalidomide in patients with advanced melanoma.
  • Determine the response rate to this combination using an extended continuous schedule at the MTD in 30 patients who have advanced metastatic melanoma without brain metastases and in 15 patients who have metastatic melanoma in the brain.
  • Further characterize the safety and toxicity of this combination in these patients.

OUTLINE: This is a dose escalation study of temozolomide (phase I) followed by a response rate determination study (phase II).

Patients receive oral temozolomide daily for 6 weeks followed by 2-4 weeks of rest. Patients receive oral thalidomide daily for the entire 8-10 week course. Treatment continues in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued to receive treatment with temozolomide and thalidomide at the recommended phase II dose.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for phase I and then an additional 45 patients (15 with CNS disease, 30 without CNS disease) will be accrued for phase II of this study within 18 months.

Keywords
iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma
Medical subject headings
Uveal Melanoma, Melanoma

What participants receive

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

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 1999
  3. Primary completionAug 2004
  4. Study completionAug 2004

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 1/2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005815
Sponsor's protocol ID
99-103
Other IDs
CDR0000067818, NCI-G00-1786
Status last verified
Jun 2013
First submitted
2 Jun 2000
Last updated
19 Jun 2013
Results posted
No

Publications

  • Hwu WJ, Krown SE, Menell JH, Panageas KS, Merrell J, Lamb LA, Williams LJ, Quinn CJ, Foster T, Chapman PB, Livingston PO, Wolchok JD, Houghton AN. Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma. J Clin Oncol. 2003 Sep 1;21(17):3351-6. doi: 10.1200/JCO.2003.02.061.

    PubMed 12947072

  • Hwu WJ, Krown SE, Panageas KS, Menell JH, Chapman PB, Livingston PO, Williams LJ, Quinn CJ, Houghton AN. Temozolomide plus thalidomide in patients with advanced melanoma: results of a dose-finding trial. J Clin Oncol. 2002 Jun 1;20(11):2610-5. doi: 10.1200/JCO.2002.09.034.

    PubMed 12039921

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing temozolomide and thalidomide in people with Intraocular Melanoma and Melanoma (Skin), 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 19 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 combined 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.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005815, which also lists 2 linked publications.

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 19 Jun 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in