Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma
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ClinicalTrials.gov Identifier: NCT01656980 |
Recruitment Status : Unknown
Verified August 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd.
Recruitment status was: Not yet recruiting
First Posted : August 3, 2012
Last Update Posted : August 3, 2012
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Condition or disease | Intervention/treatment | Phase |
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Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma | Drug: Carmustine Procedure: tumor resection surgery | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 236 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma |
Study Start Date : | August 2012 |
Estimated Primary Completion Date : | August 2014 |
Estimated Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
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Experimental: Carmustine Sustained Release Implant
For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.
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Drug: Carmustine
As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.
Other Names:
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Sham Comparator: Tumor Resection Surgery
For subjects in this control group, they accept no implants while gliomas maximally be resected.
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Procedure: tumor resection surgery
For this group, subjects will accept routine tumor resection surgery and place no implant wafers.
Other Name: blank control group |
- Overall Survival [ Time Frame: 15 months ]
- Progress Free Survival [ Time Frame: 15 months ]
- Overall Survival Rate at 12 months [ Time Frame: 15 months ]
- Karnofsky Performance Status(KPS) [ Time Frame: 15 months ]
- Quality of Life(QOL) [ Time Frame: 15 months ]
- Safety of intracranially implanted carmustine after maximal tumor resection [ Time Frame: 15 months ]Occurrence rate of adverse event and serious adverse event revealed by laboratory test outcomes including blood routine and chemistry as well as physical examination, vital signs including blood pressure, temperature, respiratory rate , heart rate.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmation of high grade glioma(WHO III or above)by frozen or squash preparation;
- Patients must be 18 to 70 years old, signed ICF;
- At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas);
- KPS ≥ 60;
- Unilateral, Supratentorial, solitary lesion and not crossing the midline
- No obvious important organ dysfunction: Hepatic function:Serum total bilirubin ≤1.5 times upper limit of laboratory normal; Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)<2.5 times upper limit of laboratory normal; Renal function:Serum creatinine ≤1.5 times upper limit of laboratory normal;
- Not Pregnant or lactating for women of childbearing potential.
Exclusion Criteria:
- Underwent cytoreductive surgery(excluded stereotactic biopsy);
- With chemotherapy or brain radiotherapy history;
- Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;
- Concomitant with other life-threatening diseases and with life expectancy <12 months;
- Allergic to nitrosourea drugs;
- With history of intracranial radiotherapy or implant chemotherapy;
- With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control;
- Experienced > 3 times of Large epilepsy within one month preoperatively.
- Investigators thought unsuitable for enrollment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656980
Contact: Yan H Sun, M.D. | +86-1360-1389-945 | sunyanhui1109@yahoo.com.cn | |
Contact: Jian J Yu, Master | +86-15336402751 | yujj@lanjin.cn |
China, Beijing | |
Beijing Tiantan Hospital Affiliated to Capital Medical University | Not yet recruiting |
Beijing, Beijing, China, 100050 | |
Contact: Yan H Sun, M.D. +86-1360-1389-945 sunyanhui1109@yahoo.com.cn | |
Contact: Jian J Yu, Master +86-15336402751 Yujj@lanjin.cn |
Principal Investigator: | Yan H Sun, M.D. | Beijing Tiantan Hospital |
Additional Information:
Responsible Party: | Shandong Lanjin Pharmaceuticals Co.,Ltd |
ClinicalTrials.gov Identifier: | NCT01656980 History of Changes |
Other Study ID Numbers: |
LJ-Glioma 3. 3.0 Version |
First Posted: | August 3, 2012 Key Record Dates |
Last Update Posted: | August 3, 2012 |
Last Verified: | August 2012 |
Additional relevant MeSH terms:
Glioblastoma Astrocytoma Glioma Oligodendroglioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Carmustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |