Castrate Resistant Prostate CancerPhase 2/3MEL-CAPNCT01907009
A Phase II Study Evaluating Intravenous Melphalan With Autologous Whole Blood Stem Cell Transplantation Over Three Cycles In Patients With Castration-Resistant Prostate Cancer (MEL-CAP)
A Phase 2/3 study testing Melphalan and Lenograstim in people with Castrate Resistant Prostate Cancer, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen blockade) is common place. Following the failure of such an approach, several strategies may be employed. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castrate Resistant Prostate Cancer
- What is being tested?
- Melphalan and Lenograstim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to 22 Dec 2016
- Phase
- Phase 2/3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged ≥18 years
- Histological diagnosis of prostate cancer
- Progressive Castration-resistant Prostate Cancer defined as:
- a rising PSA; or
- development of new sites of disease in the presence of a suppressed testosterone (<1.5 nmol/l); or
- if testosterone >1.5 nmol/l, maximum androgen blockade failure (MAB) (MAB = GnRH analogue and peripheral anti-androgen - flutamide 250 mg 3x/day or bicalutamide 50 mg/ day or cyproterone 100mg 3x/day)
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- ECOG performance status 0-2
- Adequate haematological reserve:
- Unsupported Hb >9.0 g/l
- Platelets >100x109/l
- WBC >3x109/l
- Neutrophils >1.5x109/l
- Renal sufficiency:
- •Creatinine <200 µmol/l
- Hepatic sufficiency:
- Bilirubin <30 µmol/l
- ALT <3xULN unless due to liver metastasis
- Able to give written informed consent and comply with the protocol study procedures
Who cannot join
- Patients who have suffered a previous hypersensitivity reaction to melphalan
- Patients with known hypersensitivity to lenograstim or to any of the excipients
- History of myeloid malignancy
- Lenograstim should not be administered concurrently with cytotoxic chemotherapy (i.e. on the same day)
- Previous invasive carcinoma <3 years prior to study entry
- Cardiac condition contra-indicating large volume venesection (i.e., active angina or cardiac failure)
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- Current treatment with another investigational medicinal (chemotherapeutic) product or participation in another investigational therapeutic (chemotherapy)study, at any time during the treatment period and 30 days preceding study entry.
- Life expectancy <12 weeks
- Unwilling or unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen blockade) is common place. Following the failure of such an approach, several strategies may be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that this is viewed by many as the standard of care for fit patients.
Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that median overall survival is 22 months, which is higher than the median survival rate of 19 months for Docetaxel
Read more
Data from a previous phase I study has proved the successful administration of higher doses of IV Melphalan in combination with autologous blood infusion in patients with Castration-resistant prostate cancer.
Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan, however slow platelet recovery meant longer periods of platelet transfusion. For this study we intend to assess the efficacy of an intensified intravenous melphalan with autologous whole blood stem cell transplantation over three treatment cycles.
39 patients will be enrolled over a 3 year period and at least 17 patients need to survive progression free at least 6-months for this study to be considered positive.
Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs:
MELPHALAN and LENOGRASTIM for 3 cycles alternately.
- Conditions
- Castrate Resistant Prostate Cancer
- Being tested
- Melphalan, Lenograstim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
Patients will receive Melphalan in three cycles In the first cycle they recieve 60mg/m2 and then 40mg/m2 in the next two cycles.
LenograstimDrug
Starting Lenograstim will be at 10mcg/kg/day and between cycles at 10mcg/kgs/day.
After the third cycle patient will receive 263mcg/day for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Registration. | Experimental | MELCAP study has only one arm. All suitable patients will receive 3 cycles of melphalan and lenograstim alternately.
Patient will start with a 3 day lenograstim (at 10mcg/kg/day) to boost up the blood cell count.
Upon reaching sufficient blood cell count, patients will undergo a venesection and roughly a pint of blood is taken. After this patients will receive first cycle of Melphalan (60mg/m2). The following day patient will receive back the previously given whole blood. A treament break of 6 days between the cycles is given. After the break the patient will be given Lenograstim (10mcg/kg/day)for 6 days (until sufficient).
The above regimen is repeated for cycle 2 and cycle 3 with only exception of Melphalan is given at 40mg/m2. After the cycle 3, Lenograstrim is given at 263 mcg/day for 10 days.
Upon treatment completion, patients will be followed for 2 years. If the patients show disease progression, they will start hormone therapy. Receives: Drug: Melphalan; Drug: Lenograstim |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of intensified intravenous Melphalan with autologous whole blood stem cell transplantation in patients with castration resistant prostate cancer using progression free survival.
Measured: 6 months progression free survival
Secondary outcomes (5)
To determine weather early falls (two weeks)in circulating tumor cells (CTC)predict the progression free survival
Measured: 2 weeks
To assess the changes in prostate specific antigen pre and post treament
Measured: 6 months
To study progression free survival and overall survival
Measured: 6 months.
To assess the effect of this schedule in reintroduction of hormone senstivity
Measured: 6 months
To study the Quality of life.
QLQ-30 and PR-25 questionnaires will be collected.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJan 2013
- Primary completion22 Dec 2016
- Study completion22 Dec 2016
Why it stopped: Early termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castrate Resistant Prostate CancerStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Shamash, MD FRCP, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907009
- Sponsor's protocol ID
- PR 2012 06
- Other IDs
- 2012-000351-14
- Acronym
- MEL-CAP
- Status last verified
- May 2020
- First submitted
- 22 Jul 2013
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating Intravenous Melphalan With Autologous Whole Blood Stem Cell Transplantation Over Three Cycles In Patients With Castration-Resistant Prostate Cancer (MEL-CAP)
- ClinicalTrials.gov ID
- NCT01907009
- Acronym / sponsor ID
- MEL-CAP / PR 2012 06
- Conditions
- Castrate Resistant Prostate Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 24 Jul 2013 (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.
The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen blockade) is common place. Following the failure of such an approach, several strategies may be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that this is viewed by many as the standard of care for fit patients.
Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that median overall survival is 22 months, which is higher than the median survival rate of 19 months for Docetaxel
Data from a previous phase I study has proved the successful administration of higher doses of IV Melphalan in combination with autologous blood infusion in patients with Castration-resistant prostate cancer.
Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan, however slow platelet recovery meant longer periods of platelet transfusion. For this study we intend to assess the efficacy of an intensified intravenous melphalan with autologous whole blood stem cell transplantation over three treatment cycles.
39 patients will be enrolled over a 3 year period and at least 17 patients need to survive progression free at least 6-months for this study to be considered positive.
Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs:
MELPHALAN and LENOGRASTIM for 3 cycles alternately.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registration. | Experimental | Drug: Melphalan, Drug: LenograstimMELCAP study has only one arm. All suitable patients will receive 3 cycles of melphalan and lenograstim alternately. Patient will start with a 3 day lenograstim (at 10mcg/kg/day) to boost up the blood cell count. Upon reaching sufficient blood cell count, patients will undergo a venesection and roughly a pint of blood is taken. After this patients will receive first cycle of Melphalan (60mg/m2). The following day patient will receive back the previously given whole blood. A treament break of 6 days between the cycles is given. After the break the patient will be given Lenograstim (10mcg/kg/day)for 6 days (until sufficient). The above regimen is repeated for cycle 2 and cycle 3 with only exception of Melphalan is given at 40mg/m2. After the cycle 3, Lenograstrim is given at 263 mcg/day for 10 days. Upon treatment completion, patients will be followed for 2 years. If the patients show disease progression, they will start hormone therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Men aged ≥18 years
- Histological diagnosis of prostate cancer
- Progressive Castration-resistant Prostate Cancer defined as:
- ECOG performance status 0-2
- Adequate haematological reserve:
Key exclusion criteria (9 listed)
- Patients who have suffered a previous hypersensitivity reaction to melphalan
- Patients with known hypersensitivity to lenograstim or to any of the excipients
- History of myeloid malignancy
- Lenograstim should not be administered concurrently with cytotoxic chemotherapy (i.e. on the same day)
- Previous invasive carcinoma <3 years prior to study entry
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 |
|---|---|---|
| MelphalanPatients will receive Melphalan in three cycles In the first cycle they recieve 60mg/m2 and then 40mg/m2 in the next two cycles. | Drug | Registration. |
| LenograstimStarting Lenograstim will be at 10mcg/kg/day and between cycles at 10mcg/kgs/day. After the third cycle patient will receive 263mcg/day for 10 days. | Drug | Registration. |
Primary outcome
To determine the efficacy of intensified intravenous Melphalan with autologous whole blood stem cell transplantation in patients with castration resistant prostate cancer using progression free survival.
Time frame: 6 months progression free survival
5 secondary outcomes
To determine weather early falls (two weeks)in circulating tumor cells (CTC)predict the progression free survival
Time frame: 2 weeks
To assess the changes in prostate specific antigen pre and post treament
Time frame: 6 months
To study progression free survival and overall survival
Time frame: 6 months.
To assess the effect of this schedule in reintroduction of hormone senstivity
Time frame: 6 months
To study the Quality of life.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Early termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
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Active, not recruitingPhase 1
A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 2
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
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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.
Jonathan Shamash, MD FRCP principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melphalan and Lenograstim in people with Castrate Resistant Prostate Cancer, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 18 inclusion and 9 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: stopped early, as of the sponsor's last update on 19 Apr 2023. 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 Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Early termination). 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?
To determine the efficacy of intensified intravenous Melphalan with autologous whole blood stem cell transplantation in patients with castration resistant prostate cancer using progression free survival. (time frame: 6 months progression free survival). 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 19 Apr 2023.