MelanomaPhase 2NCT00383851
Randomized Trial of ATN-224 and Temozolomide in Advanced Melanoma
A Phase 2 study testing ATN-224 and Temozolomide in people with Melanoma, run by Attenuon at 17 sites in United States.
Trial summary
This is a multicenter, randomized, phase II study to evaluate the safety and efficacy of oral ATN-224 plus temozolomide in patients with advanced melanoma. Patients will be randomized (1:1) between temozolomide and ATN-224 and temozolomide followed by ATN-224. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- ATN-224 and Temozolomide
- How many people
- 60 participants
- Where
- 17 sitesUnited States
- Study dates
- Sep 2006to Sep 2008
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed, advanced cutaneous melanoma. Advanced melanoma is defined as locally advanced disease that is not amenable to surgery or radiation therapy and metastatic disease. Patients may have had adjuvant treatment for prior early disease as long as it was given at least 6 months before the first dose of study medication, and the treatment did not contain temozolomide or dacarbazine. Previous treatment for advanced disease is acceptable as long as the patient did not receive temozolomide or dacarbazine. There is no restriction on the number of prior regimens.
- Age ≥18 years
- Life expectancy of greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥50%; see Appendix A)
- Patients must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥1,500/uL
Show all 26Show fewer
- platelets ≥100,000/uL
- hemoglobin ≥9 g/dL
- total bilirubin ≤2 X institutional upper limit of normal (ULN)
- AST(SGOT) and ALT(SGPT) ≤2 X ULN
- creatinine clearance (measured or calculated) ≥30 mL/min
- Patients are allowed to receive erythropoietin or blood transfusions before receiving their first dose of ATN-224 to bring the hemoglobin level to >9 g/dL to meet eligibility criteria.
- Use of adequate contraception. Temozolomide has the potential to cause fetal harm. The effects of ATN 224 on the developing human fetus at the recommended therapeutic dose are unknown, but antiangiogenic agents are known to be teratogenic. For these reasons women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation through the follow up visit 28 days after the last dose of ATN 224 or temozolomide.
- Willingness to forgo taking copper- or zinc-containing vitamins or supplements
- Ability to understand and the willingness to sign a written informed consent document
- Uveal (ocular) melanoma
- Brain metastasis that has not been treated and remained stable for at least 4 weeks (In other words, patients are eligible if they have no metastases or if brain metastases have been treated and remain stable for at least 4 weeks)
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ATN-224 or omeprazole
- History of malabsorption syndromes or other gastrointestinal disorders that may affect ATN-224 or temozolomide absorption, including bowel obstruction, celiac disease, sprue, cystic fibrosis
- Ineligible to receive either temozolomide (Temodar®), omeprazole (Prilosec®), lansoprazole (Prevacid®), pantoprazole (Protonix®), or ranitidine (Zantac®)
- Inability to swallow study medication capsules
- Other serious medical or psychiatric illness preventing informed consent or with the potential to interfere with assessment of safety or efficacy of ATN-224 treatment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients known to be positive for HIV or infectious hepatitis type A, B or C
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Who cannot join
None listed.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
The Harry and Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Billings Clinic
Billings, Montana, 59101
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee
Oncology Hematology Care
Cincinati, Ohio, 45242
Mary Crowley Medical Research Center
Dallas, Texas, 75246
University of Colorado Health Science Center
Denver, Colorado, 80262
Pacific Oncology and Hematology
Encinitas, California, 92024
Florida Cancer Specialists
Fort Myers, Florida, 33901
Cancer Center of the Carolinas
Greenville, South Carolina, 29605
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, 70006
Mountainside Hospital Cancer Center - The Melanoma Center
Montclair, New Jersey, 07042
Tennessee Oncology
Nashville, Tennessee, 37203
Hematology - Oncology Group of Orange, Inc.
Orange, California, 92868
UCI Chao Family Comprehensive Cancer Center
Orange, California, 92868
The Angeles Clinic
Santa Monica, California, 90404
Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Randomized Phase II Trial of ATN-224 in Combination With Temozolomide or Temozolomide Followed by ATN-224 in Patients With Advanced Melanoma
This is a multicenter, randomized, phase II study to evaluate the safety and efficacy of oral ATN-224 plus temozolomide in patients with advanced melanoma. Patients will be randomized (1:1) between temozolomide and ATN-224 and temozolomide followed by ATN-224. Patients assigned to the sequential treatment group will receive temozolomide until progression of disease is documented and then receive ATN-224 as a single agent until documentation of progression of disease using the last tumor assessment on temozolomide therapy as the baseline assessment.
Read the detailed description
According to the National Cancer Institute PDQ database, advanced melanoma is refractory to most standard systemic therapy, and all newly diagnosed patients should be considered candidates for clinical trials. Although advanced melanoma is relatively resistant to therapy, several biologic response modifiers and cytotoxic agents have been reported to produce objective responses. Once melanoma is metastatic, treatments are palliative rather than curative. In spite of many attempts at multimodality therapy, the prognosis in this disease remains poor. Further agents are needed if progress is to be made with melanoma treatment.
ATN-224 is an orally active, small molecule that has been shown in cellular and animal models to be antiangiogenic and to have activity against melanoma cell lines. Clinical studies with a similar agent (ammonium tetrathiomolybdate) indicate that the agent can be administered continuously on a daily basis for years in some patients. ATN-224 has the potential to affect the progression of melanoma by mechanisms that include both antiangiogenic and antitumor pathways. Temozolomide, a commonly used agent for melanoma, also has a tolerable profile.
- Conditions
- Melanoma
- Being tested
- ATN-224, Temozolomide
- Keywords
- ATN-224, Temozolomide, Combination, Sequential, Anti-angiogenic, Copper
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATN-224Drug
TemozolomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
24-week progression-free survival of the combination of temozolomide with ATN 224 and of temozolomide alone
Evaluate the safety of ATN-224 in combination with or following temozolomide
Secondary outcomes (5)
Response rate (complete and partial response), rate of stable disease for ≥24 weeks, and progression-free survival for treatment with the combination of ATN 224 and temozolomide
Response rate (complete and partial response), rate of stable disease for ≥24 weeks, and progression-free survival for treatment with temozolomide alone
Response rate (complete and partial response), rate of stable disease for ≥24 weeks, and progression-free survival for treatment with ATN 224 alone after progression of disease on temozolomide
Time to treatment failure by progression of disease or death for patients receiving ATN 224 plus temozolomide and for patients receiving temozolomide followed by ATN 224
Explore blood and tumor biomarkers with the potential to correlate with activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startSep 2006
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attenuon
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gilad Gordon, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383851
- Sponsor's protocol ID
- ATN-224-008
- Status last verified
- Dec 2007
- First submitted
- 2 Oct 2006
- Last updated
- 6 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of ATN-224 in Combination With Temozolomide or Temozolomide Followed by ATN-224 in Patients With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00383851
- Acronym / sponsor ID
- ATN-224-008
- Conditions
- Melanoma
- Keywords
- ATN-224, Temozolomide, Combination, Sequential, Anti-angiogenic, Copper
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AttenuonIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Sep 2008 (estimated)
- First posted
- 4 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, phase II study to evaluate the safety and efficacy of oral ATN-224 plus temozolomide in patients with advanced melanoma. Patients will be randomized (1:1) between temozolomide and ATN-224 and temozolomide followed by ATN-224. Patients assigned to the sequential treatment group will receive temozolomide until progression of disease is documented and then receive ATN-224 as a single agent until documentation of progression of disease using the last tumor assessment on temozolomide therapy as the baseline assessment.
Detailed description
According to the National Cancer Institute PDQ database, advanced melanoma is refractory to most standard systemic therapy, and all newly diagnosed patients should be considered candidates for clinical trials. Although advanced melanoma is relatively resistant to therapy, several biologic response modifiers and cytotoxic agents have been reported to produce objective responses. Once melanoma is metastatic, treatments are palliative rather than curative. In spite of many attempts at multimodality therapy, the prognosis in this disease remains poor. Further agents are needed if progress is to be made with melanoma treatment.
ATN-224 is an orally active, small molecule that has been shown in cellular and animal models to be antiangiogenic and to have activity against melanoma cell lines. Clinical studies with a similar agent (ammonium tetrathiomolybdate) indicate that the agent can be administered continuously on a daily basis for years in some patients. ATN-224 has the potential to affect the progression of melanoma by mechanisms that include both antiangiogenic and antitumor pathways. Temozolomide, a commonly used agent for melanoma, also has a tolerable profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients with histologically confirmed, advanced cutaneous melanoma. Advanced melanoma is defined as locally advanced disease that is not amenable to surgery or radiation therapy and metastatic disease. Patients may have had adjuvant treatment for prior early disease as long as it was given at least 6 months before the first dose of study medication, and the treatment did not contain temozolomide or dacarbazine. Previous treatment for advanced disease is acceptable as long as the patient did not receive temozolomide or dacarbazine. There is no restriction on the number of prior regimens.
- Age ≥18 years
- Life expectancy of greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥50%; see Appendix A)
- Patients must have adequate organ and marrow function as defined below:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATN-224 | Drug | – |
| Temozolomide | Drug | – |
Primary outcome
24-week progression-free survival of the combination of temozolomide with ATN 224 and of temozolomide alone
Evaluate the safety of ATN-224 in combination with or following temozolomide
5 secondary outcomes
Response rate (complete and partial response), rate of stable disease for ≥24 weeks, and progression-free survival for treatment with the combination of ATN 224 and temozolomide
Response rate (complete and partial response), rate of stable disease for ≥24 weeks, and progression-free survival for treatment with temozolomide alone
Response rate (complete and partial response), rate of stable disease for ≥24 weeks, and progression-free survival for treatment with ATN 224 alone after progression of disease on temozolomide
Time to treatment failure by progression of disease or death for patients receiving ATN 224 plus temozolomide and for patients receiving temozolomide followed by ATN 224
Explore blood and tumor biomarkers with the potential to correlate with activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilad Gordon, MD study director
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATN-224 and Temozolomide in people with Melanoma, run by Attenuon at 17 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?
The sponsor lists 26 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: status not confirmed, as of the sponsor's last update on 6 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 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?
Results are not available in the source record.
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?
24-week progression-free survival of the combination of temozolomide with ATN 224 and of temozolomide alone. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 6 Dec 2007.