MelanomaPhase 1NCT00580320
Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
A Phase 1 study testing Dacarbazine and bortezomib in people with Melanoma and Soft Tissue Sarcoma, run by Virginia Commonwealth University at 2 sites in United States.
Trial summary
Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Soft Tissue Sarcoma, Parathyroid Carcinoma
- What is being tested?
- Dacarbazine and bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2004to Nov 2013
- 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
Who may be able to join
- Histologic diagnosis of cutaneous or mucosal melanoma, soft tissue sarcoma (STS), or an APUD (amine precursor uptake and decarboxylation) tumor. APUD tumors include parathyroid carcinoma, medullary carcinoma of the thyroid, small cell carcinoma of the lung, pheochromocytoma, islet cell tumors, carcinoid tumors, and malignant paraganglioma.
- Measurable or evaluable disease not appropriate for resection and/or radiation with curative intent. Patients with small cell carcinoma must have extended stage disease or, if limited stage disease, must have received at least one prior systemic therapy.
- Age 18 years or greater
- ECOG Performance Status 0 or 1
- Women must be post-menopausal, infertile as the result of a surgical procedure, or willing to use a medically accepted form of birth control (abstinence, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condon with spermicide) for the duration of study treatment. Men also must agree to use a medically accepted form of birth control for the duration of study treatment.
Who cannot join
- Uncontrolled brain metastatic disease
- Platelet count <100
- Absolute neutrophil count <1.5
- Blood transfusion or hematopoietic growth factors for cytopenia within one month of enrollment.
- Calculated or measured (Cockcroft and Gault formula) creatinine clearance <30 mL/minute
- AST > 3 times the upper limit of normal, unless elevation due to metastatic disease, in which case AST > 5 times the upper limit of normal
Show all 12Show fewer
- Bilirubin > 2 mg/mL
- Grade 2 or greater peripheral neuropathy
- Hypersensitivity to bortezomib, boron, mannitol, or dacarbazine
- Pregnant or nursing
- Other investigational drugs within 14 days of enrollment
- Other medical or other condition(s) that in the opinion of the investigator/sub-investigator might compromise the objectives of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Massey Cancer Center/Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.
Read the detailed description
The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly.
Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).
- Conditions
- Melanoma, Soft Tissue Sarcoma, Parathyroid Carcinoma, Small Cell Carcinoma of the Lung, Carcinoid Tumors
- Being tested
- Dacarbazine and bortezomib
- Keywords
- melanoma, soft tissue sarcoma, APUD tumor, dacarbazine, bortezomib, velcade
- Medical subject headings
- Melanoma, Sarcoma, Parathyroid Neoplasms, Small Cell Lung Carcinoma, Carcinoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dacarbazine and bortezomibDrug
Also called bortezomib (velcade)
Level 0: Dacarbazine 190 mg/m2 + Bortezomib 1.0 mg/m2; Level 1: Dacarbazine 250 mg/m2 + Bortezomib 1.0 mg/m2; Level 2: Dacarbazine 250 mg/m2 + Bortezomib 1.3 mg/m2; Level 3: Dacarbazine 250 mg/m2 + Bortezomib 1.6 mg/m2; Level 4: Dacarbazine 330 mg/m2 + Bortezomib 1.6 mg/m2; Level 5: Dacarbazine 440 mg/m2 + Bortezomib 1.6 mg/m2; Level 6: Dacarbazine 580 mg/m2 + Bortezomib 1.6 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | dacarbazine + bortezomib Receives: Drug: Dacarbazine and bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by serious adverse events
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startSep 2004
- Primary completionOct 2009
- Study completionNov 2013
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.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Poklepovic, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580320
- Sponsor's protocol ID
- MCC-03740
- Status last verified
- Aug 2016
- First submitted
- 18 Dec 2007
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00580320
- Acronym / sponsor ID
- MCC-03740
- Conditions
- Melanoma, Soft Tissue Sarcoma, Parathyroid Carcinoma, Small Cell Carcinoma of the Lung, Carcinoid Tumors
- Keywords
- melanoma, soft tissue sarcoma, APUD tumor, dacarbazine, bortezomib, velcade
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Dec 2007 (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.
Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.
Detailed description
The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly.
Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Dacarbazine and bortezomibdacarbazine + bortezomib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologic diagnosis of cutaneous or mucosal melanoma, soft tissue sarcoma (STS), or an APUD (amine precursor uptake and decarboxylation) tumor. APUD tumors include parathyroid carcinoma, medullary carcinoma of the thyroid, small cell carcinoma of the lung, pheochromocytoma, islet cell tumors, carcinoid tumors, and malignant paraganglioma.
- Measurable or evaluable disease not appropriate for resection and/or radiation with curative intent. Patients with small cell carcinoma must have extended stage disease or, if limited stage disease, must have received at least one prior systemic therapy.
- Age 18 years or greater
- ECOG Performance Status 0 or 1
- Women must be post-menopausal, infertile as the result of a surgical procedure, or willing to use a medically accepted form of birth control (abstinence, hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condon with spermicide) for the duration of study treatment. Men also must agree to use a medically accepted form of birth control for the duration of study treatment.
Key exclusion criteria (12 listed)
- Uncontrolled brain metastatic disease
- Platelet count <100
- Absolute neutrophil count <1.5
- Blood transfusion or hematopoietic growth factors for cytopenia within one month of enrollment.
- Calculated or measured (Cockcroft and Gault formula) creatinine clearance <30 mL/minute
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 |
|---|---|---|
| Dacarbazine and bortezomibAlso: bortezomib (velcade)Level 0: Dacarbazine 190 mg/m2 + Bortezomib 1.0 mg/m2; Level 1: Dacarbazine 250 mg/m2 + Bortezomib 1.0 mg/m2; Level 2: Dacarbazine 250 mg/m2 + Bortezomib 1.3 mg/m2; Level 3: Dacarbazine 250 mg/m2 + Bortezomib 1.6 mg/m2; Level 4: Dacarbazine 330 mg/m2 + Bortezomib 1.6 mg/m2; Level 5: Dacarbazine 440 mg/m2 + Bortezomib 1.6 mg/m2; Level 6: Dacarbazine 580 mg/m2 + Bortezomib 1.6 mg/m2 | Drug | A |
Primary outcome
Safety as measured by serious adverse events
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- PublicationLink provided by the sponsor.
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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.
Andrew Poklepovic, MD principal investigator
Massey Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dacarbazine and bortezomib in people with Melanoma and Soft Tissue Sarcoma, run by Virginia Commonwealth University at 2 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 5 inclusion and 12 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
What does the primary outcome measure?
Safety as measured by serious adverse events (time frame: 4 years). 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 18 Aug 2016.