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Alkylating Agent
Thalidomide + Dacarbazine for Melanoma
Phase 2
Waitlist Available
Research Sponsored by National Center for Research Resources (NCRR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status > 2
All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether combining thalidomide with dacarbazine (the standard treatment for advanced melanoma) can help shrink tumors while causing less toxicity than dacarbazine alone.
Who is the study for?
This trial is for patients with metastatic melanoma who can measure their lesions and meet certain blood, liver function, and kidney health standards. They must not have other cancers except specific skin or cervical conditions, cannot be pregnant or breastfeeding, and need to use birth control. Those who've had DTIC or thalidomide treatments before are excluded.Check my eligibility
What is being tested?
The trial tests the combination of thalidomide (an oral drug that blocks tumor blood vessel growth) with dacarbazine (DTIC), a standard treatment for metastatic melanoma known to shrink tumors in some patients. The goal is to see if this combo increases response rates without excessive toxicity.See study design
What are the potential side effects?
Potential side effects include those related to thalidomide's impact on blood vessels which could lead to various organ issues, as well as typical chemotherapy-related effects from DTIC such as nausea, fatigue, lowered immunity leading to increased infection risk, and possible liver impairment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need considerable assistance and cannot care for myself.
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I understand the risks of birth defects with thalidomide and can follow instructions to prevent pregnancy.
Select...
I have no cancer history, except possibly treated skin cancer or cervical pre-cancer.
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I have melanoma that has spread to other parts of my body.
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I have never been treated with DTIC or thalidomide.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
National Center for Research Resources (NCRR)Lead Sponsor
537 Previous Clinical Trials
317,016 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the risks of birth defects with thalidomide and can follow instructions to prevent pregnancy.I need considerable assistance and cannot care for myself.I am using effective birth control methods.I have no cancer history, except possibly treated skin cancer or cervical pre-cancer.I have melanoma that has spread to other parts of my body.I have never been treated with DTIC or thalidomide.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial accept participants who are age 85 or older?
"This clinical trial is limited to those aged 18-65. For minors and elderly adults, there are 52 trials for the former group and 742 studies available for seniors."
Answered by AI
Has this treatment obtained regulatory endorsement from the FDA?
"The safety of this intervention has been evaluated and our team at Power have assigned it a score of 2 on the scale from 1 to 3. This is because Phase 2 trials only provide limited assurances that the treatment will not be harmful, but no evidence yet exists regarding its efficacy."
Answered by AI
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