Refractory Multiple MyelomaPhase 1NCT00028821
2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing 2-methoxyestradiol, pharmacological study and laboratory biomarker analysis in people with Refractory Multiple Myeloma and Stage III Multiple Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors. 2-methoxyestradiol may stop or slow the growth of solid tumors by stopping blood flow to the tumor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Multiple Myeloma, Stage III Multiple Myeloma, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- 2-methoxyestradiol, pharmacological study and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Apr 2006
- 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
- Histologically confirmed solid tumor that is clinically unresectable
- No known standard therapy that is potentially curative or definitely capable of extending life expectancy
- Patients with multiple myeloma may be enrolled to expansion cohort once the recommended phase II dose is established
- Tumor amenable to serial biopsy
- No bone metastases as only site of disease
- No CNS metastases
Show all 37Show fewer
- Performance status - ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10.0 g/dL
- Bilirubin normal
- AST no greater than 2.5 times upper limit of normal (ULN)
- Creatinine no greater than 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- Adequate oral intake
- No malabsorption syndrome
- No disease of terminal small bowel
- No dysphagia or other condition that would interfere with ability to swallow intact capsules
- No clinical contraindications (e.g., anticoagulant therapy) to biopsy
- No uncontrolled infection
- No seizure disorder
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 4 weeks since prior biologic therapy
- More than 4 weeks since prior immunotherapy
- No concurrent immunotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No concurrent chemotherapy
- No concurrent megestrol
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
- No concurrent radiotherapy
- No prior extensive resection of terminal small bowel
- No prior major resection of the stomach or proximal small bowel
- No other concurrent ancillary investigational therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I and Pharmacologic Study of 2-Methoxyestradiol in Patients With Advanced Solid Tumors
Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors. 2-methoxyestradiol may stop or slow the growth of solid tumors by stopping blood flow to the tumor
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the optimal biologic dose and/or maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors.
II. Determine the qualitative and quantitative toxic effects of this drug in these patients.
III. Determine the pharmacokinetics and metabolism of this drug in these patients.
IV. Determine the biologic changes within the tumor of these patients when treated with this drug.
- Correlate the pharmacokinetics and toxicity of this drug in these patients. VI. Evaluate the biologic evidence of angiogenesis inhibition in patients receiving this drug.
VII. Correlate genetic polymorphisms in cytochrome P450 and sulfotransferases isoforms with the pharmacokinetics of this drug.
OUTLINE: This is a dose-escalation study.
Patients receive oral 2-methoxyestradiol (2-ME) once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 2-ME until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 42-60 patients will be accrued for this study within 19 months.
- Conditions
- Refractory Multiple Myeloma, Stage III Multiple Myeloma, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- 2-methoxyestradiol, pharmacological study, laboratory biomarker analysis
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-methoxyestradiolDrug
Also called 2-ME, 2-Methoxy Estradiol, 2ME2, Panzem
Given orally
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (2-methoxyestradiol) | Experimental | Patients receive oral 2-methoxyestradiol (2-ME) once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: 2-methoxyestradiol; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by Common Toxicity Criteria (CTC) version 2.0
Presented primarily in a descriptive fashion.
Measured: 28 days
Number of toxicity incidents as assessed by CTC version 2.0
Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.
Measured: Up to 3 months after completion of treatment
Secondary outcomes (3)
Biologic activity rate (BAR)
A rate will be calculated by dividing the number of patients with BA by the number of patients treated at the phase II recommended dose level.
Measured: At day 1 and at day 28
Angiogenesis inhibition via an ex vivo angiogenesis assay
The relationship between each marker and dose level will be explored descriptively.
Measured: At day 1 and at day 28
Number of responses
Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease.
Measured: Up to 3 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2002
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Charles Erlichman, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028821
- Sponsor's protocol ID
- NCI-2012-02439
- Other IDs
- MC0017, U01CA069912, CDR0000069137
- Status last verified
- Jan 2013
- First submitted
- 4 Jan 2002
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I and Pharmacologic Study of 2-Methoxyestradiol in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00028821
- Acronym / sponsor ID
- NCI-2012-02439
- Conditions
- Refractory Multiple Myeloma, Stage III Multiple Myeloma, Unspecified Adult Solid Tumor, Protocol Specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2002
- Primary completion
- Apr 2006 (actual)
- First posted
- 27 Jan 2003 (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.
Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors. 2-methoxyestradiol may stop or slow the growth of solid tumors by stopping blood flow to the tumor
Detailed description
PRIMARY OBJECTIVES:
- Determine the optimal biologic dose and/or maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors.
II. Determine the qualitative and quantitative toxic effects of this drug in these patients.
III. Determine the pharmacokinetics and metabolism of this drug in these patients.
IV. Determine the biologic changes within the tumor of these patients when treated with this drug.
- Correlate the pharmacokinetics and toxicity of this drug in these patients. VI. Evaluate the biologic evidence of angiogenesis inhibition in patients receiving this drug.
VII. Correlate genetic polymorphisms in cytochrome P450 and sulfotransferases isoforms with the pharmacokinetics of this drug.
OUTLINE: This is a dose-escalation study.
Patients receive oral 2-methoxyestradiol (2-ME) once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 2-ME until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 42-60 patients will be accrued for this study within 19 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (2-methoxyestradiol) | Experimental | Drug: 2-methoxyestradiol, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive oral 2-methoxyestradiol (2-ME) once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Histologically confirmed solid tumor that is clinically unresectable
- Tumor amenable to serial biopsy
- No bone metastases as only site of disease
- No CNS metastases
- Performance status - ECOG 0-2
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 |
|---|---|---|
| 2-methoxyestradiolAlso: 2-ME, 2-Methoxy Estradiol, 2ME2, PanzemGiven orally | Drug | Treatment (2-methoxyestradiol) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (2-methoxyestradiol) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (2-methoxyestradiol) |
Primary outcome
Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by Common Toxicity Criteria (CTC) version 2.0
Time frame: 28 days
Presented primarily in a descriptive fashion.
Number of toxicity incidents as assessed by CTC version 2.0
Time frame: Up to 3 months after completion of treatment
Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.
3 secondary outcomes
Biologic activity rate (BAR)
Time frame: At day 1 and at day 28
Angiogenesis inhibition via an ex vivo angiogenesis assay
Time frame: At day 1 and at day 28
Number of responses
Time frame: Up to 3 months after completion of treatment
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 16 Jan 2013.
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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.
Charles Erlichman principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2-methoxyestradiol, pharmacological study and laboratory biomarker analysis in people with Refractory Multiple Myeloma and Stage III Multiple Myeloma, 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 37 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 16 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 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?
Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by Common Toxicity Criteria (CTC) version 2.0 (time frame: 28 days). 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 16 Jan 2013.